No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00852108006411 | 02-100-03-VEX | VX-23310 | Synthetic bone graft substitute in particulate form composed of beta-tricalcium Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure. | MQV | Filler, Bone Void, Calcium Compound | 2 | Callisto Granules Beta-TCP Synthetic Bone Graft |
2 | 00852108006404 | 02-050-03-VEX | VX-23305 | Synthetic bone graft substitute in particulate form composed of beta-tricalcium Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure. | MQV | Filler, Bone Void, Calcium Compound | 2 | Callisto Granules Beta-TCP Synthetic Bone Graft |
3 | 00852108006381 | 02-200-02-VEX | VX-12020 | Synthetic bone graft substitute in particulate form composed of beta-tricalcium Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure. | MQV | Filler, Bone Void, Calcium Compound | 2 | Callisto Granules Beta-TCP Synthetic Bone Graft |
4 | 00852108006206 | 04-010-01-SAS | OST405 | Synthetic bone graft substitute in particulate form composed of beta-tricalcium Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone. | LYC | Bone Grafting Material, Synthetic | 2 | Osteo-i Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules |
5 | 00852108006190 | 04-005-01-SAS | OST404 | Synthetic bone graft substitute in particulate form composed of beta-tricalcium Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone. | LYC | Bone Grafting Material, Synthetic | 2 | Osteo-i Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules |
6 | 00856509002935 | 08-015-00-V04 | 08-015-00-V04 | Renú Gel Vocal Fold Implant is a sterile, semi-solid, cohesive implant indicated Renú Gel Vocal Fold Implant is a sterile, semi-solid, cohesive implant indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue-bulking agent. | MIX | System, Vocal Cord Medialization | 2 | Renú Gel |
7 | 00856509002294 | 08-015-04-V04 | 08-015-04-V04 | Renú Calcium Hydroxylapatite Vocal Fold Implant is a sterile, semi-solid, cohesi Renú Calcium Hydroxylapatite Vocal Fold Implant is a sterile, semi-solid, cohesive implant indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue-bulking agent. | MIX | System, Vocal Cord Medialization | 2 | Renú Voice |
8 | 00852108006299 | 04-010-01-BSB | BTCP251 | Synthetic bone graft substitute in particulate form composed of beta-tricalcium Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone. | LYC | Bone Grafting Material, Synthetic | 2 | Bio TCP Beta-Tricalcium Phosphate Porous Granulate |
9 | 00856509002669 | 12-000-00-ND1 | 12-000-00-ND1 | Renú Transoral Needle is a manual surgical instrument intended to deliver inject Renú Transoral Needle is a manual surgical instrument intended to deliver injectable soft tissue filling devices to the vocal folds for vocal fold medialization and/or treatment of vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. The needle is a single use device and is provided sterile and ready to use. | GAA | Needle, Aspiration And Injection, Disposable | 1 | Renú Transoral Needle |
10 | 00852108006282 | 04-030-02-MIL | 04-030-02-MIL | Synthetic bone graft substitute in particulate form composed of beta-tricalcium Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone. | LYC | Bone Grafting Material, Synthetic | 2 | Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules |
11 | 00852108006275 | 04-010-02-MIL | 04-010-02-MIL | Synthetic bone graft substitute in particulate form composed of beta-tricalcium Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone. | LYC | Bone Grafting Material, Synthetic | 2 | Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules |
12 | 00852108006268 | 04-005-02-MIL | 04-005-02-MIL | Synthetic bone graft substitute in particulate form composed of beta-tricalcium Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone. | LYC | Bone Grafting Material, Synthetic | 2 | Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules |
13 | 00852108006251 | 04-030-01-MIL | 04-030-01-MIL | Synthetic bone graft substitute in particulate form composed of beta-tricalcium Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone. | LYC | Bone Grafting Material, Synthetic | 2 | Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules |
14 | 00852108006244 | 04-010-01-MIL | 04-010-01-MIL | Synthetic bone graft substitute in particulate form composed of beta-tricalcium Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone. | LYC | Bone Grafting Material, Synthetic | 2 | Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules |
15 | 00852108006237 | 04-005-01-MIL | 04-005-01-MIL | Synthetic bone graft substitute in particulate form composed of beta-tricalcium Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone. | LYC | Bone Grafting Material, Synthetic | 2 | Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules |
16 | 00856509002812 | 04-005-01-RGP | 04-005-01-RGP | Synthetic bone graft substitute in particulate form composed of beta-tricalcium Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone. | LYC | Bone Grafting Material, Synthetic | 2 | RegenPerio Dental Beta-TCP |
17 | 00856509002706 | 02-100-02-RGO | 02-100-02-RGO | Synthetic bone graft substitute in particulate form composed of beta-tricalcium Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure. | MQV | Filler, Bone Void, Calcium Compound | 2 | RegenOsteo Orthopedic Beta-TCP |
18 | 00856509002690 | 02-050-02-RGO | 02-050-02-RGO | Synthetic bone graft substitute in particulate form composed of beta-tricalcium Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure. | MQV | Filler, Bone Void, Calcium Compound | 2 | RegenOsteo Orthopedic Beta-TCP |
19 | 00856509002638 | 02-100-03-VTX | 202937-10 | Synthetic bone graft substitute in particulate form composed of beta-tricalcium Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure. | MQV | Filler, Bone Void, Calcium Compound | 2 | Trab-X SB Synthetic Bone Matrix |
20 | 00856509002621 | 02-050-03-VTX | 202937-05 | Synthetic bone graft substitute in particulate form composed of beta-tricalcium Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure. | MQV | Filler, Bone Void, Calcium Compound | 2 | Trab-X SB Synthetic Bone Matrix |
21 | 00856509002584 | 02-050-02-VTX | 102937-05 | Synthetic bone graft substitute in particulate form composed of beta-tricalcium Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure. | MQV | Filler, Bone Void, Calcium Compound | 2 | Trab-X SB Synthetic Bone Matrix |
22 | 00852108006510 | 02-100-03-VTX | 202937-10 | Synthetic bone graft substitute in particulate form composed of beta-tricalcium Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure. | MQV | Filler, Bone Void, Calcium Compound | 2 | Regento Regenerative Scaffold |
23 | 00852108006329 | 04-030-01-PIB | 04-030-01-PIB | Synthetic bone graft substitute in particulate form composed of beta-tricalcium Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone. | LYC | Bone Grafting Material, Synthetic | 2 | Bank-It Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules |
24 | 00852108006312 | 04-010-01-PIB | 04-010-01-PIB | Synthetic bone graft substitute in particulate form composed of beta-tricalcium Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone. | LYC | Bone Grafting Material, Synthetic | 2 | Bank-It Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules |
25 | 00852108006305 | 04-005-01-PIB | 04-005-01-PIB | Synthetic bone graft substitute in particulate form composed of beta-tricalcium Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone. | LYC | Bone Grafting Material, Synthetic | 2 | Bank-It Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules |
26 | 00852108006183 | 03-030-01-SAS | OST413 | Synthetic bone graft substitute in particulate form composed of biphasic calcium Synthetic bone graft substitute in particulate form composed of biphasic calcium phosphate intended for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone. | LYC | Bone Grafting Material, Synthetic | 2 | Osteo-i Synthetic Biphasic Dental Bone Graft Granules |
27 | 00852108006176 | 03-010-01-SAS | OST402 | Synthetic bone graft substitute in particulate form composed of biphasic calcium Synthetic bone graft substitute in particulate form composed of biphasic calcium phosphate intended for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone. | LYC | Bone Grafting Material, Synthetic | 2 | Osteo-i Synthetic Biphasic Dental Bone Graft Granules |
28 | 00852108006169 | 03-005-01-SAS | OST401 | Synthetic bone graft substitute in particulate form composed of biphasic calcium Synthetic bone graft substitute in particulate form composed of biphasic calcium phosphate intended for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone. | LYC | Bone Grafting Material, Synthetic | 2 | Osteo-i Synthetic Biphasic Dental Bone Graft Granules |
29 | 00852108006152 | 03-030-02-MIL | 03-030-02-MIL | Synthetic bone graft substitute in particulate form composed of biphasic calcium Synthetic bone graft substitute in particulate form composed of biphasic calcium phosphate intended for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone. | LYC | Bone Grafting Material, Synthetic | 2 | Implant Logistics Synthetic Biphasic Dental Bone Graft Granules |
30 | 00852108006138 | 03-005-02-MIL | 03-005-02-MIL | Synthetic bone graft substitute in particulate form composed of biphasic calcium Synthetic bone graft substitute in particulate form composed of biphasic calcium phosphate intended for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone. | LYC | Bone Grafting Material, Synthetic | 2 | Implant Logistics Synthetic Biphasic Dental Bone Graft Granules |
31 | 00852108006121 | 03-030-01-MIL | 03-030-01-MIL | Synthetic bone graft substitute in particulate form composed of biphasic calcium Synthetic bone graft substitute in particulate form composed of biphasic calcium phosphate intended for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone. | LYC | Bone Grafting Material, Synthetic | 2 | Implant Logistics Synthetic Biphasic Dental Bone Graft Granules |
32 | 00852108006114 | 03-010-01-MIL | 03-010-01-MIL | Synthetic bone graft substitute in particulate form composed of biphasic calcium Synthetic bone graft substitute in particulate form composed of biphasic calcium phosphate intended for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone. | LYC | Bone Grafting Material, Synthetic | 2 | Implant Logistics Synthetic Biphasic Dental Bone Graft Granules |
33 | 00852108006107 | 03-005-01-MIL | 03-005-01-MIL | Synthetic bone graft substitute in particulate form composed of biphasic calcium Synthetic bone graft substitute in particulate form composed of biphasic calcium phosphate intended for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone. | LYC | Bone Grafting Material, Synthetic | 2 | Implant Logistics Synthetic Biphasic Dental Bone Graft Granules |
34 | 00856509002959 | 02-030-03-ZVG | 02-030-03-ZVG | Synthetic bone graft substitute in particulate form composed of beta-tricalcium Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure. | MQV | Filler, Bone Void, Calcium Compound | 2 | Zavation ZV Graft Beta-TCP Synthetic Bone Graft |
35 | 00856509002942 | 02-030-02-ZVG | 02-030-02-ZVG | Synthetic bone graft substitute in particulate form composed of beta-tricalcium Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure. | MQV | Filler, Bone Void, Calcium Compound | 2 | Zavation ZV Graft Beta-TCP Synthetic Bone Graft |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 50601557114230 | Genex® Bone Graft Substitute 10cc | 910-010 | Genex® Bone Graft Substitute is a simple to use synthetic resorbable material de Genex® Bone Graft Substitute is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible.The kit contains a powder and mixing solution which, when combined, provides a mouldable cohesive paste for introduction into a syringe. When injected the mixture sets to form Genex® Bone Graft Substitute a hard but resorbable matrix. Genex® Bone Graft Substitute is supplied sterile. | Genex® | BIOCOMPOSITES LTD |
2 | 50601557114162 | Genex® Bone Graft Substitute 5cc | 910-005 | Genex® Bone Graft Substitute is a simple to use synthetic resorbable material de Genex® Bone Graft Substitute is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible.The kit contains a powder and mixing solution which, when combined, provides a mouldable cohesive paste for introduction into a syringe. When injected the mixture sets to form Genex® Bone Graft Substiute, a hard but resorbable matrix. Genex® Bone Graft Substitute is supplied sterile. | Genex® | BIOCOMPOSITES LTD |
3 | 50601557110966 | 11-2002 | 11-2002 | geneX® is a simple to use synthetic resorbable material designed to promote rege geneX® is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. One component of the matrix prevents soft tissue in-growth until it is resorbed and replaced by new bony tissue. Another component has been shown to act as a scaffold through which new bone grows. The kit contains a powder and mixing solution which, when combined, provides a mouldable cohesive paste for introduction into a syringe. When injected the mixture sets to form geneX®; a hard but resorbable matrix. | geneX® ds | BIOCOMPOSITES LTD |
4 | 50601557110898 | 11-2005 | 11-2005 | geneX® is a simple to use synthetic resorbable material designed to promote rege geneX® is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. One component of the matrix prevents soft tissue in-growth until it is resorbed and replaced by new bony tissue. Another component has been shown to act as a scaffold through which new bone grows. The kit contains a powder and mixing solution which, when combined, provides a mouldable cohesive paste for introduction into a syringe. When injected the mixture sets to form geneX®; a hard but resorbable matrix. | geneX® ds | BIOCOMPOSITES LTD |
5 | 50601557110584 | 640-005 | 640-005 | Stimulan® DS Calcium Sulfate Bone Void Filler is provided sterile for single pat Stimulan® DS Calcium Sulfate Bone Void Filler is provided sterile for single patient use. The kit contains calcium sulfate powder and mixing solution in pre-measured quantities so that when mixed together, the resultant paste is to be injected or digitally packed into open bone/gap to cure insitu. The biodegradable, radiopaque mixture is resorbed in approximately 30-60 days when used in accordance with the device labelling. Stimulan® is manufactured from synthetic implant grade calcium sulfate dihydrate (CaS04, 2H20) that resporbs and is replaced with bone during the healing process. Also as the bone void filler is biodegradable and biocompatible; it may be used at an infected site. | Stimulan® DS | BIOCOMPOSITES LTD |
6 | 50601557110416 | 620-020 | 620-020 | STIMULAN® Rapid Cure provided sterile for single patient use. STIMULAN® Rapid Cu STIMULAN® Rapid Cure provided sterile for single patient use. STIMULAN® Rapid Cure contains calcium sulfate powder and mixing solution in pre-measured quantities so that when mixed together in a sterile mixing bowl, the resultant paste is to be digitally packed into open bone void/gap to set insitu or placed into the mould provided, the mixture sets to form beads. The biodegradable, radiopaque beads are resorbed in approximately 30 – 60 days when used in accordance with the device labelling. STIMULAN® Rapid Cure is manufactured from synthetic implant grade calcium sulfate dihydrate(CaSO4.2H2O) that resorbs and is replaced with bone during the healing process. Also, as the bone void filler beads are biodegradable and biocompatible, they may be used at an infected site. | Stimulan® Rapid Cure | BIOCOMPOSITES LTD |
7 | 50601557110348 | 620-010 | 620-010 | STIMULAN® Rapid Cure provided sterile for single patient use. STIMULAN® Rapid Cu STIMULAN® Rapid Cure provided sterile for single patient use. STIMULAN® Rapid Cure contains calcium sulfate powder and mixing solution in pre-measured quantities so that when mixed together in a sterile mixing bowl, the resultant paste is to be digitally packed into open bone void/gap to set insitu or placed into the mould provided, the mixture sets to form beads. The biodegradable, radiopaque beads are resorbed in approximately 30 – 60 days when used in accordance with the device labelling. STIMULAN® Rapid Cure is manufactured from synthetic implant grade calcium sulfate dihydrate(CaSO4.2H2O) that resorbs and is replaced with bone during the healing process. Also, as the bone void filler beads are biodegradable and biocompatible, they may be used at an infected site. | Stimulan® Rapid Cure | BIOCOMPOSITES LTD |
8 | 50601557110270 | 620-005 | 620-005 | STIMULAN® Rapid Cure provided sterile for single patient use. STIMULAN® Rapid Cu STIMULAN® Rapid Cure provided sterile for single patient use. STIMULAN® Rapid Cure contains calcium sulfate powder and mixing solution in pre-measured quantities so that when mixed together in a sterile mixing bowl, the resultant paste is to be digitally packed into open bone void/gap to set insitu or placed into the mould provided, the mixture sets to form beads. The biodegradable, radiopaque beads are resorbed in approximately 30 – 60 days when used in accordance with the device labelling. STIMULAN® Rapid Cure is manufactured from synthetic implant grade calcium sulfate dihydrate(CaSO4.2H2O) that resorbs and is replaced with bone during the healing process. Also, as the bone void filler beads are biodegradable and biocompatible, they may be used at an infected site. | Stimulan® Rapid Cure | BIOCOMPOSITES LTD |
9 | 50601557109694 | 980-005 | 980-005 | geneX® is a simple to use synthetic resorbable material designed to promote rege geneX® is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. One component of the matrix prevents soft tissue in-growth until it is resorbed and replaced by new bony tissue. Another component has been shown to act as a scaffold through which new bone grows. The kit contains a powder and mixing solution which, when combined, provides a mouldable cohesive paste for introduction into a syringe.When injected the mixture sets to form geneX®; a hard but resorbable matrix. | geneX® ds | BIOCOMPOSITES LTD |
10 | 50601557109526 | 980-002 | 980-002 | geneX® is a simple to use synthetic resorbable material designed to promote rege geneX® is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. One component of the matrix prevents soft tissue in-growth until it is resorbed and replaced by new bony tissue. Another component has been shown to act as a scaffold through which new bone grows. The kit contains a powder and mixing solution which, when combined, provides a mouldable cohesive paste for introduction into a syringe.When injected the mixture sets to form geneX®; a hard but resorbable matrix. | geneX® ds | BIOCOMPOSITES LTD |
11 | 50601557101810 | 920-010 | 920-010 | geneX® Putty consists of an inorganic framework of calcium based ions. geneX® Pu geneX® Putty consists of an inorganic framework of calcium based ions. geneX® Putty has been bioengineered to mimic human bone. It is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. geneX® Putty is a non-setting putty and is supplied sterile. | geneX® putty | BIOCOMPOSITES LTD |
12 | 50601557101742 | 920-005 | 920-005 | geneX® putty consists of an inorganic framework of calcium based ions. geneX® Pu geneX® putty consists of an inorganic framework of calcium based ions. geneX® Putty has been bioengineered to mimic human bone. It is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. geneX® Putty is a non-setting putty and is supplied sterile. | geneX® Putty | BIOCOMPOSITES LTD |
13 | 50601557101674 | 920-002 | 920-002 | geneX® Putty consists of an inorganic framework of calcium based ions. geneX® Pu geneX® Putty consists of an inorganic framework of calcium based ions. geneX® Putty has been bioengineered to mimic human bone. It is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. geneX® Putty is a non-setting putty and is supplied sterile. | geneX® putty | BIOCOMPOSITES LTD |
14 | 50601557101506 | 900-010 | 900-010 | geneX® is a simple to use synthetic resorbable material designed to promote rege geneX® is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible.The kit contains a powder and mixing solution which, when combined, provides a mouldable cohesive paste for introduction into a syringe. When injected the mixture sets to form geneX® a hard but resorbable matrix. geneX® is supplied sterile | geneX® | BIOCOMPOSITES LTD |
15 | 50601557101438 | 900-005 | 900-005 | geneX® is a simple to use synthetic resorbable material designed to promote rege geneX® is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible.The kit contains a powder and mixing solution which, when combined, provides a mouldable cohesive paste for introduction into a syringe. When injected the mixture sets to form geneX® a hard but resorbable matrix. geneX® is supplied sterile | geneX® | BIOCOMPOSITES LTD |
16 | 50601557101292 | 600-010 | 600-010 | STIMULAN® Kit - provided sterile for single patient use. STIMULAN® Kit contains STIMULAN® Kit - provided sterile for single patient use. STIMULAN® Kit contains calcium sulfate powder and mixing solution in pre-measured quantities so that when mixed together in a sterile mixing bowl, the resultant paste is to be injected or digitally packed into open bone void/gap to set in situ or placed into the mould provided, the mixture sets to form beads. The biodegradable, radiopaque beads are resorbed in approximately 30 – 60 days when used in accordance with the device labelling. STIMULAN® Kit is manufactured from synthetic implant grade calcium sulfate dihydrate (CaSO4.2H2O) that resorbs and is replaced with bone during the healing process. Also as the bone void filler beads are biodegradable and biocompatible, they may be used at an infected site. | Stimulan® Kit | BIOCOMPOSITES LTD |
17 | 50601557101124 | 600-005 | 600-005 | STIMULAN® Kit - provided sterile for single patient use. STIMULAN® Kit contains STIMULAN® Kit - provided sterile for single patient use. STIMULAN® Kit contains calcium sulfate powder and mixing solution in pre-measured quantities so that when mixed together in a sterile mixing bowl, the resultant paste is to be injected or digitally packed into open bone void/gap to set in situ or placed into the mould provided, the mixture sets to form beads. The biodegradable, radiopaque beads are resorbed in approximately 30 – 60 days when used in accordance with the device labelling. STIMULAN® Kit is manufactured from synthetic implant grade calcium sulfate dihydrate (CaSO4.2H2O) that resorbs and is replaced with bone during the healing process. Also as the bone void filler beads are biodegradable and biocompatible, they may be used at an infected site. | Stimulan® Kit | BIOCOMPOSITES LTD |
18 | 50601557100998 | 600-30-s1 | 600-30-s1 | Stimulan® Calcium Sulfate Bone Void Filler pellets are provided sterile for sing Stimulan® Calcium Sulfate Bone Void Filler pellets are provided sterile for single patient use. The biodegradable, radiopaque pellets are resorbed in approximately 30-60 days when used in accordance with the device labelling. Calcium Sulfate Bone Filler is manufactured from medical grade calcium sulfate dihydrate (CaSO4 2H20) and stearic acid that resorbs and is replaced with bone during the healing process. Also as the bone void filler pellets are biodegradable and biocompatible, they may be used at an infected site. | Stimulan® Dispenser | BIOCOMPOSITES LTD |
19 | 50601557100752 | 600-48-010 | 600-48-010 | Stimulan® Calcium Sulfate Bone Void Filler pellets are provided sterile for sing Stimulan® Calcium Sulfate Bone Void Filler pellets are provided sterile for single patient use. The biodegradable, radiopaque pellets are resorbed in approximately 30-60 days when used in accordance with the device labelling. Calcium Sulfate Bone Filler is manufactured from medical grade calcium sulfate dihydrate (CaSO4 2H20) and stearic acid that resorbs and is replaced with bone during the healing process. Also as the bone void filler pellets are biodegradable and biocompatible, they may be used at an infected site. | Stimulan® Pellets | BIOCOMPOSITES LTD |
20 | 50601557100516 | 600-30-005 | 600-30-005 | Stimulan® Calcium Sulfate Bone Void Filler pellets are provided sterile for sing Stimulan® Calcium Sulfate Bone Void Filler pellets are provided sterile for single patient use. The biodegradable, radiopaque pellets are resorbed in approximately 30-60 days when used in accordance with the device labelling. Calcium Sulfate Bone Filler is manufactured from medical grade calcium sulfate dihydrate (CaSO4 2H20) and stearic acid that resorbs and is replaced with bone during the healing process. Also as the bone void filler pellets are biodegradable and biocompatible, they may be used at an infected site. | Stimulan® Pellets | BIOCOMPOSITES LTD |
21 | 50601557100448 | 800-020 | 800-020 | Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is provided sterile for Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is provided sterile for single patient use. The biodegradable, radiopaque granules/blocks are resorbed in approximately 6-12 months when used in accordance with the device labelling. Biocomposites Tri-Calcium Phosphate Bone Graft Substitute is manufactured from medical grade Tri-Calcium Phosphate. Numerous bone graft operations are undertaken every year to repair bone defects caused by surgery, tumours, trauma, infections and other damage. Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is intended for use in clinical situations where the use of autologous grafts or other bone graft substitutes maybe undesirable, due either to the risk of associated infection or unavailability. Allogran-R® resorbs and is replaced with bone during the healing process. | Allogran-R® | BIOCOMPOSITES LTD |
22 | 50601557100370 | 800-010 | 800-010 | Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is provided sterile for Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is provided sterile for single patient use. The biodegradable, radiopaque granules/blocks are resorbed in approximately 6-12 months when used in accordance with the device labelling. Biocomposites Tri-Calcium Phosphate Bone Graft Substitute is manufactured from medical grade Tri-Calcium Phosphate. Numerous bone graft operations are undertaken every year to repair bone defects caused by surgery, tumours, trauma, infections and other damage. Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is intended for use in clinical situations where the use of autologous grafts or other bone graft substitutes maybe undesirable, due either to the risk of associated infection or unavailability. Allogran-R® resorbs and is replaced with bone during the healing process. | Allogran-R® | BIOCOMPOSITES LTD |
23 | 50601557100202 | 800-005 | 800-005 | Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is provided sterile for Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is provided sterile for single patient use. The biodegradable, radiopaque granules/blocks are resorbed in approximately 6-12 months when used in accordance with the device labelling. Biocomposites Tri-Calcium Phosphate Bone Graft Substitute is manufactured from medical grade Tri-Calcium Phosphate. Numerous bone graft operations are undertaken every year to repair bone defects caused by surgery, tumours, trauma, infections and other damage. Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is intended for use in clinical situations where the use of autologous grafts or other bone graft substitutes maybe undesirable, due either to the risk of associated infection or unavailability. Allogran-R® resorbs and is replaced with bone during the healing process. | Allogran-R® | BIOCOMPOSITES LTD |
24 | W4184428025T0473 | 428025 | 428025 | DBX Putty 2.5cc | DBX® | MUSCULOSKELETAL TRANSPLANT FOUNDATION, INC. |
25 | W4184428010T0473 | 428010 | 428010 | DBX Putty 1cc | DBX® | MUSCULOSKELETAL TRANSPLANT FOUNDATION, INC. |
26 | W4184428005T0473 | 428005 | 428005 | DBX Putty 0.5cc | DBX® | MUSCULOSKELETAL TRANSPLANT FOUNDATION, INC. |
27 | W4184420810T0473 | 420810 | 420810 | Legacy DBM, 10CC | Legacy DBM | MUSCULOSKELETAL TRANSPLANT FOUNDATION, INC. |
28 | W4184420805T0473 | 420805 | 420805 | Legacy DBM, 5CC | Legacy DBM | MUSCULOSKELETAL TRANSPLANT FOUNDATION, INC. |
29 | W4184420802T0473 | 420802 | 420802 | Legacy DBM, 2.5CC | Legacy DBM | MUSCULOSKELETAL TRANSPLANT FOUNDATION, INC. |
30 | W4184420801T0473 | 420801 | 420801 | Legacy DBM, 1CC | Legacy DBM | MUSCULOSKELETAL TRANSPLANT FOUNDATION, INC. |
31 | W4184420800T0473 | 420800 | 420800 | Legacy DBM, 0.5cc | Legacy DBM | MUSCULOSKELETAL TRANSPLANT FOUNDATION, INC. |
32 | W4184228025T0473 | 228025 | 228025 | DBX Putty 2.5cc | DBX® | MUSCULOSKELETAL TRANSPLANT FOUNDATION, INC. |
33 | W4184228010T0473 | 228010 | 228010 | DBX Putty 1cc | DBX® | MUSCULOSKELETAL TRANSPLANT FOUNDATION, INC. |
34 | W4184228005T0473 | 228005 | 228005 | DBX Putty 0.5cc | DBX® | MUSCULOSKELETAL TRANSPLANT FOUNDATION, INC. |
35 | W4184227060T0473 | 227060 | 227060 | AFT-DS Straight Tube (7/8-filled) | DBX® | MUSCULOSKELETAL TRANSPLANT FOUNDATION, INC. |
36 | W4184227055T0473 | 227055 | 227055 | AFT-DS Diverted Tube (7/8-filled) | DBX® | MUSCULOSKELETAL TRANSPLANT FOUNDATION, INC. |
37 | W4184227010T0473 | 227010 | 227010 | AFT Straight Tube (1/2 Filled) | DBX® | MUSCULOSKELETAL TRANSPLANT FOUNDATION, INC. |
38 | W4184227007T0473 | 227007 | 227007 | AFT Straight Tube (3/4 Filled) | DBX | MUSCULOSKELETAL TRANSPLANT FOUNDATION, INC. |
39 | W4184227005T0473 | 227005 | 227005 | AFT Diverted Tube (3/4 Filled) | DBX® | MUSCULOSKELETAL TRANSPLANT FOUNDATION, INC. |
40 | W4184068100T0473 | 068100 | 068100 | DBX Putty Inject 10cc | DBX® | MUSCULOSKELETAL TRANSPLANT FOUNDATION, INC. |
41 | W4184068050T0473 | 068050 | 068050 | DBX Putty Inject 5cc | DBX® | MUSCULOSKELETAL TRANSPLANT FOUNDATION, INC. |
42 | W4184068025T0473 | 068025 | 068025 | DBX Inject Putty 2.5cc | DBX® | MUSCULOSKELETAL TRANSPLANT FOUNDATION, INC. |
43 | W4184058200T0474 | 058200 | 058200 | DBX Mix, 20cc | DBX® | MUSCULOSKELETAL TRANSPLANT FOUNDATION, INC. |
44 | W4184058100T0474 | 058100 | 058100 | DBX Mix, 10cc | DBX® | MUSCULOSKELETAL TRANSPLANT FOUNDATION, INC. |
45 | W4184058050T0474 | 058050 | 058050 | DBX Mix, 5cc | DBX® | MUSCULOSKELETAL TRANSPLANT FOUNDATION, INC. |
46 | W4184058025T0474 | 058025 | 058025 | DBX Mix, 2.5cc | DBX® | MUSCULOSKELETAL TRANSPLANT FOUNDATION, INC. |
47 | W4184048150T0479 | 048150 | 048150 | DBX Strip Trauma 5cm x 5cm | DBX® | MUSCULOSKELETAL TRANSPLANT FOUNDATION, INC. |
48 | W4184048125T0479 | 048125 | 048125 | DBX Strip Trauma 2.5cm x 5cm | DBX® | MUSCULOSKELETAL TRANSPLANT FOUNDATION, INC. |
49 | W4184048050T0479 | 048050 | 048050 | DBX Strip 5cm x 5cm | DBX® | MUSCULOSKELETAL TRANSPLANT FOUNDATION, INC. |
50 | W4184048025T0479 | 048025 | 048025 | DBX Strip 2.5cm x 5cm | DBX® | MUSCULOSKELETAL TRANSPLANT FOUNDATION, INC. |