| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 03700501803274 | 670-22-06 | 670-22-06 | Synthetic Bone Graft Wedge | MQV | Filler, Bone Void, Calcium Compound | 2 | OpteMx |
| 2 | 03700501802406 | 670-12-04 | 670-12-04 | Synthetic Bone GraftSticks | MQV | Filler, Bone Void, Calcium Compound | 2 | OpteMx |
| 3 | 03700501810876 | LE9902G02 | LE9902G02 | Synthetic Resorbable Bone GraftGranules | MQV | Filler, Bone Void, Calcium Compound | 2 | OssGro |
| 4 | 03700501810524 | LE9801B04 | LE9801B04 | Synthetic Resorbable Bone GraftSticks | MQV | Filler, Bone Void, Calcium Compound | 2 | OssGro |
| 5 | 03700501810517 | LE9801B02 | LE9801B02 | Synthetic Resorbable Bone GraftSticks | MQV | Filler, Bone Void, Calcium Compound | 2 | OssGro |
| 6 | 03700501810500 | LE9912C01 | LE9912C01 | Synthetic Resorbable Bone GraftWedge | MQV | Filler, Bone Void, Calcium Compound | 2 | OssGro |
| 7 | 03700501810494 | LE9910C01 | LE9910C01 | Synthetic Resorbable Bone GraftWedge | MQV | Filler, Bone Void, Calcium Compound | 2 | OssGro |
| 8 | 03700501810487 | LE9908C01 | LE9908C01 | Synthetic Resorbable Bone GraftWedge | MQV | Filler, Bone Void, Calcium Compound | 2 | OssGro |
| 9 | 03700501810470 | LE9906C01 | LE9906C01 | Synthetic Resorbable Bone GraftWedge | MQV | Filler, Bone Void, Calcium Compound | 2 | OssGro |
| 10 | 03700501810463 | LE9905C01 | LE9905C01 | Synthetic Resorbable Bone GraftWedge | MQV | Filler, Bone Void, Calcium Compound | 2 | OssGro |
| 11 | 03700501810456 | LE1414C01 | LE1414C01 | Synthetic Resorbable Bone GraftWedge | MQV | Filler, Bone Void, Calcium Compound | 2 | OssGro |
| 12 | 03700501810449 | LE0112C01 | LE0112C01 | Synthetic Resorbable Bone GraftWedge | MQV | Filler, Bone Void, Calcium Compound | 2 | OssGro |
| 13 | 03700501810432 | LE0110C01 | LE0110C01 | Synthetic Resorbable Bone GraftWedge | MQV | Filler, Bone Void, Calcium Compound | 2 | OssGro |
| 14 | 03700501810425 | LE0108C01 | LE0108C01 | Synthetic Resorbable Bone GraftWedge | MQV | Filler, Bone Void, Calcium Compound | 2 | OssGro |
| 15 | 03700501810418 | LE0106C01 | LE0106C01 | Synthetic Resorbable Bone GraftWedge | MQV | Filler, Bone Void, Calcium Compound | 2 | OssGro |
| 16 | 03700501810401 | LE9802B04 | LE9802B04 | Synthetic Resorbable Bone GraftSticks | MQV | Filler, Bone Void, Calcium Compound | 2 | OssGro |
| 17 | 03700501810371 | LE9802B02 | LE9802B02 | Synthetic Resorbable Bone GraftSticks | MQV | Filler, Bone Void, Calcium Compound | 2 | OssGro |
| 18 | 03700501810364 | LE0603G30 | LE0603G30 | Synthetic Resorbable Bone GraftGranules | MQV | Filler, Bone Void, Calcium Compound | 2 | OssGro |
| 19 | 03700501810357 | LE0803G20 | LE0803G20 | Synthetic Resorbable Bone GraftGranules | MQV | Filler, Bone Void, Calcium Compound | 2 | OssGro |
| 20 | 03700501810340 | LE9903G10 | LE9903G10 | Synthetic Resorbable Bone GraftGranules | MQV | Filler, Bone Void, Calcium Compound | 2 | OssGro |
| 21 | 03700501810333 | LE0503G05 | LE0503G05 | Synthetic Resorbable Bone GraftGranules | MQV | Filler, Bone Void, Calcium Compound | 2 | OssGro |
| 22 | 03700501810326 | LE0602G30 | LE0602G30 | Synthetic Resorbable Bone GraftGranules | MQV | Filler, Bone Void, Calcium Compound | 2 | OssGro |
| 23 | 03700501810319 | LE9902G10 | LE9902G10 | Synthetic Resorbable Bone GraftGranules | MQV | Filler, Bone Void, Calcium Compound | 2 | OssGro |
| 24 | 03700501810296 | LE1102GS05 | LE1102GS05 | Synthetic Resorbable Bone GraftSyringe | MQV | Filler, Bone Void, Calcium Compound | 2 | OssGro |
| 25 | 03700501806961 | 1101PU25DE | 1101PU25DE | Synthetic Resorbable Bone Graft Injectable | LYC | Bone Grafting Material, Synthetic | 2 | IN'OSS |
| 26 | 03700501806541 | 1002PU50DE | 1002PU50DE | Synthetic Resorbable Bone Graft Injectable | LYC | Bone Grafting Material, Synthetic | 2 | IN'OSS |
| 27 | 03700501806534 | 1001PU01DE | 1001PU01DE | Synthetic Resorbable Bone Graft Injectable | LYC | Bone Grafting Material, Synthetic | 2 | IN'OSS |
| 28 | H132001109132151 | 00-1109-132-15 | 00-1109-132-15 | Synthetic Bone Resorbable GraftCone 12 | MQV | Filler, Bone Void, Calcium Compound | 2 | TRIOSITE |
| 29 | H132001109115021 | 00-1109-115-02 | 00-1109-115-02 | Synthétic Bone Resorbable GraftGranules 2-4mm 16cc | MQV | Filler, Bone Void, Calcium Compound | 2 | TRIOSITE |
| 30 | H132001109115011 | 00-1109-115-01 | 00-1109-115-01 | Synthetic bone Resorbable GraftGranules 2-3mm | MQV | Filler, Bone Void, Calcium Compound | 2 | TRIOSITE |
| 31 | H132001109114021 | 00-1109-114-02 | 00-1109-114-02 | Synthetic Bone Resorbable GraftStick 5x5x20mm | MQV | Filler, Bone Void, Calcium Compound | 2 | TRIOSITE |
| 32 | H132001109113011 | 00-1109-113-01 | 00-1109-113-01 | Synthetic Bone Resorbable GraftStick 5x5x10mm | MQV | Filler, Bone Void, Calcium Compound | 2 | TRIOSITE |
| 33 | H132001109085151 | 00-1109-085-15 | 00-1109-085-15 | Synthetic Bone Resorbable GraftCone | MQV | Filler, Bone Void, Calcium Compound | 2 | TRIOSITE |
| 34 | H132001109006121 | 00-1109-006-12 | 00-1109-006-12 | Synthetic Bone Resorbable GraftWedge 12mm | MQV | Filler, Bone Void, Calcium Compound | 2 | TRIOSITE |
| 35 | H132001109005251 | 00-1109-005-25 | 00-1109-005-25 | Synthetic Bone Resorbable GraftDisc | MQV | Filler, Bone Void, Calcium Compound | 2 | TRIOSITE |
| 36 | H132001109005101 | 00-1109-005-10 | 00-1109-005-10 | Synthetic Bone Resorbable GraftWedge 10mm | MQV | Filler, Bone Void, Calcium Compound | 2 | TRIOSITE |
| 37 | H132001109000481 | 00-1109-000-48 | 00-1109-000-48 | Synthetic Bone Resorbable GraftWedge 8mm | MQV | Filler, Bone Void, Calcium Compound | 2 | TRIOSITE |
| 38 | H132001109000361 | 00-1109-000-36 | 00-1109-000-36 | Synthetic Bone Resorbable GraftWedge 6mm | MQV | Filler, Bone Void, Calcium Compound | 2 | TRIOSITE |
| 39 | H132000060130001 | 00-0060-130-00 | 00-0060-130-00 | Synthetic Bone Resorbable Graft Granules 0.5-1mm | MQV | Filler, Bone Void, Calcium Compound | 2 | TRIOSITE |
| 40 | H131001109114011 | 00-1109-114-01 | 00-1109-114-01 | Synthetic Bone Resorbable GraftStick 5x5x20mm | MQV | Filler, Bone Void, Calcium Compound | 2 | TRIOSITE |
| 41 | H131001109113021 | 00-1109-113-02 | 00-1109-113-02 | synthetic Bone Resorbable GraftStick 5x5x10mm | MQV | Filler, Bone Void, Calcium Compound | 2 | TRIOSITE |
| 42 | 03700501813280 | SB0414D01 | SB0414D01 | Synthetic Bone SubstituteCylinder Diam 14mm, Height 20mm | MQV | Filler, Bone Void, Calcium Compound | 2 | RESORBA Synthetic Bone |
| 43 | 03700501813273 | SB0410D01 | SB0410D01 | Synthetic Bone SubstituteCylinder Diam 10mm, Height 20mm | MQV | Filler, Bone Void, Calcium Compound | 2 | RESORBA Synthetic Bone |
| 44 | 03700501813266 | SB0412D01 | SB0412D01 | Synthetic Bone SubstituteCylinder Diam 12mm, Height 20mm | MQV | Filler, Bone Void, Calcium Compound | 2 | RESORBA Synthetic Bone |
| 45 | 03700501813259 | SB9908C01 | SB9908C01 | Synthetic Bone SubstituteWedge base 8mm (x1) | MQV | Filler, Bone Void, Calcium Compound | 2 | RESORBA Synthetic Bone |
| 46 | 03700501813242 | SB9910C01 | SB9910C01 | Synthetic Bone SubstituteWedge base 10mm (x1) | MQV | Filler, Bone Void, Calcium Compound | 2 | RESORBA Synthetic Bone |
| 47 | 03700501813235 | SB9912C01 | SB9912C01 | Synthetic Bone SubstituteWedge base 12mm (x1) | MQV | Filler, Bone Void, Calcium Compound | 2 | RESORBA Synthetic Bone |
| 48 | 03700501813228 | SB0408D01 | SB0408D01 | Synthetic Bone SubstituteCylinder Diam 8mm, Height 20mm | MQV | Filler, Bone Void, Calcium Compound | 2 | RESORBA Synthetic Bone |
| 49 | 03700501813211 | SB0409D01 | SB0409D01 | Synthetic Bone SubstituteCylinder Diam 9.5mm, Height 20mm | MQV | Filler, Bone Void, Calcium Compound | 2 | RESORBA Synthetic Bone |
| 50 | 03700501813136 | SB9906C01 | SB9906C01 | Synthetic Bone SubstituteWedge base 6mm (x1) | MQV | Filler, Bone Void, Calcium Compound | 2 | RESORBA Synthetic Bone |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | B0101000259 | 100-0259 | Vitrium E Instruments | BIO2 TECHNOLOGIES | BIO2 TECHNOLOGIES, INC. | |
| 2 | B0101000258 | 100-0258 | Vitrium C Instruments | BIO2 TECHNOLOGIES | BIO2 TECHNOLOGIES, INC. | |
| 3 | B01010002321 | 1000232 | VITRIUM CLARGE, 8 x 23 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 4 | B01010002311 | 1000231 | VITRIUM CMEDIUM, 8 x 23 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 5 | B01010000721 | 1000072 | VITRIUM CSMALL, 7 x 20 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 6 | B01010000711 | 1000071 | VITRIUM CSMALL, 6 x 20 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 7 | B01010000701 | 1000070 | VITRIUM CSMALL, 5 x 20 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 8 | B01010000691 | 1000069 | VITRIUM CSMALL, 4 x 20 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 9 | B01010000681 | 1000068 | VITRIUM CSMALL, 7 x 16 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 10 | B01010000671 | 1000067 | VITRIUM CSMALL, 6 x 16 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 11 | B01010000661 | 1000066 | VITRIUM CSMALL, 5 x 16 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 12 | B01010000651 | 1000065 | VITRIUM CSMALL, 4 x 16 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 13 | B01010000641 | 1000064 | VITRIUM CLARGE, 7 x 23 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 14 | B01010000631 | 1000063 | VITRIUM CLARGE, 6 x 23 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 15 | B01010000621 | 1000062 | VITRIUM CMEDIUM, 7 x 23 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 16 | B01010000611 | 1000061 | VITRIUM CMEDIUM, 6 x 23 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 17 | B01010000601 | 1000060 | VITRIUM CMEDIUM, 7 x 20 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 18 | B01010000591 | 1000059 | VITRIUM CMEDIUM, 6 x 20 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 19 | B01010000581 | 1000058 | VITRIUM CMEDIUM, 5 x 20 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 20 | B01010000571 | 1000057 | VITRIUM CMEDIUM, 4 x 20 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 21 | B01010000561 | 1000056 | VITRIUM CMEDIUM, 7 x 16 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 22 | B01010000551 | 1000055 | VITRIUM CMEDIUM, 6 x 16 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 23 | B01010000541 | 1000054 | VITRIUM CMEDIUM, 5 x 16 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 24 | B01010000531 | 1000053 | VITRIUM CMEDIUM, 4 x 16 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 25 | B01010000521 | 1000052 | VITRIUM E22 x 10 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 26 | B01010000511 | 1000051 | VITRIUM E22 x 9 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 27 | B01010000501 | 1000050 | VITRIUM E22 x 8 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 28 | B01010000491 | 1000049 | VITRIUM E22 x 7 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 29 | B01010000481 | 1000048 | VITRIUM E22 x 6 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 30 | B01010000471 | 1000047 | VITRIUM E22 x 5 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 31 | B01010000461 | 1000046 | VITRIUM E20 x 10 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 32 | B01010000451 | 1000045 | VITRIUM E20 x 9 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 33 | B01010000441 | 1000044 | VITRIUM E20 x 8 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 34 | B01010000431 | 1000043 | VITRIUM E20 x 7 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 35 | B01010000421 | 1000042 | VITRIUM E20 x 6 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 36 | B01010000411 | 1000041 | VITRIUM E20 x 5 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 37 | B01010000401 | 1000040 | VITRIUM E18 x 10 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 38 | B01010000391 | 1000039 | VITRIUM E18 x 9 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 39 | B01010000381 | 1000038 | VITRIUM E18 x 8 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 40 | B01010000371 | 1000037 | VITRIUM E18 x 7 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 41 | B01010000361 | 1000036 | VITRIUM E18 x 6 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 42 | B01010000351 | 1000035 | VITRIUM E18 x 5 | Bio2 Technologies | BIO2 TECHNOLOGIES, INC. | |
| 43 | 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 |
| 44 | 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 |
| 45 | 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 |
| 46 | 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 |
| 47 | 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 |
| 48 | 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 |
| 49 | 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 |
| 50 | 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 |