No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 10850001118207 | LBWDF | Dental Wound Dressing Foam, 2cm x 4cm x 3mm | KGN | Dressing, Wound, Collagen | GEM™ Wound Dressing Foam | ||
2 | 00850001118187 | LBSB200 | Synthetic Mineral-Collagen Composite Bone Graft, 2.0cc (11mm x 21mm) | NPL | Barrier, Animal Source, Intraoral | 2 | GEM™ Synthetic Bone Graft | |
3 | 00850001118170 | LBSB100 | Synthetic Mineral-Collagen Composite Bone Graft, 1.0cc (11mm x 10mm) | NPL | Barrier, Animal Source, Intraoral | 2 | GEM™ Synthetic Bone Graft | |
4 | 00850001118163 | LBSB050 | Synthetic Mineral-Collagen Composite Bone Graft, 0.5cc (9mm x 8mm) | NPL | Barrier, Animal Source, Intraoral | 2 | GEM™ Synthetic Bone Graft | |
5 | 00850001118064 | LBEXT3040 | Resorbable Collagen Membrane, 30mm x 40mm | NPL | Barrier, Animal Source, Intraoral | 2 | GEM Extend™ | |
6 | 00850001118057 | LBEXT2030 | Resorbable Collagen Membrane, 20mm x 30mm | NPL | Barrier, Animal Source, Intraoral | 2 | GEM Extend™ | |
7 | 00850001118040 | LBEXT1520 | Resorbable Collagen Membrane, 15mm x 20mm | NPL | Barrier, Animal Source, Intraoral | 2 | GEM Extend™ | |
8 | 00850001118002 | LBGEM05 | Growth-Factor Enhanced Matrix for Periodontal Regeneration | NPZ,NQA | Bone Grafting Material, Dental, With Biologic Component,Biologic Material, Dental | 3 | GEM 21S® | |
9 | 10850001118191 | LBWDT | Dental Wound Dressing Tape, 2.5cm x7.5cm x 1mm | KGN | Dressing, Wound, Collagen | GEM™ Wound Dressing Tape | ||
10 | 00850001118071 | LBCAP1216 | Resorbable Collagen Membrane, 12mm x 16mm | NPL | Barrier, Animal Source, Intraoral | 2 | GEM Cap™ | |
11 | 00850001118156 | LBNBS05 | Osteoconductive Bone Matrix in Syringe, 0.5cc (Particle Size 0.25-1.0mm) | NPM | Bone Grafting Material, Animal Source | 2 | GEM™ Bone Graft | |
12 | 00850001118149 | LBNBS025 | Osteoconductive Bone Matrix in Syringe, 0.25cc (Particle Size 0.25-1.0mm) | NPM | Bone Grafting Material, Animal Source | 2 | GEM™ Bone Graft | |
13 | 00850001118132 | LBNB2020 | Osteoconductive Bone Matrix, 2.0cc (Particle Size 1.0-2.0mm) | NPM | Bone Grafting Material, Animal Source | 2 | GEM™ Bone Graft | |
14 | 00850001118125 | LBNB1020 | Osteoconductive Bone Matrix, 1.0cc (Particle Size 1.0-2.0mm) | NPM | Bone Grafting Material, Animal Source | 2 | GEM™ Bone Graft | |
15 | 00850001118118 | LBNB4010 | Osteoconductive Bone Matrix, 4.0cc (Particle Size 0.25-1.0mm) | NPM | Bone Grafting Material, Animal Source | 2 | GEM™ Bone Graft | |
16 | 00850001118101 | LBNB2010 | Osteoconductive Bone Matrix, 2.0cc (Particle Size 0.25-1.0mm) | NPM | Bone Grafting Material, Animal Source | 2 | GEM™ Bone Graft | |
17 | 00850001118088 | LBNB0510 | Osteoconductive Bone Matrix, 0.5cc (Particle Size 0.25-1.0mm) | NPM | Bone Grafting Material, Animal Source | 2 | GEM™ Bone Graft | |
18 | 10850001118214 | LBWDP | Dental Wound Dressing Plug, 10 x 20mm | KGN | Dressing, Wound, Collagen | GEM™ Wound Dressing Plug | ||
19 | 00850001118033 | LBADAPT3040 | Resorbable Collagen Membrane, 30mm x 40mm | NPL | Barrier, Animal Source, Intraoral | 2 | GEM Adapt™ | |
20 | 00850001118026 | LBADAPT2030 | Resorbable Collagen Membrane, 20mm x 30mm | NPL | Barrier, Animal Source, Intraoral | 2 | GEM Adapt™ | |
21 | 00850001118019 | LBADAPT1520 | Resorbable Collagen Membrane, 15mm x 20mm | NPL | Barrier, Animal Source, Intraoral | 2 | GEM Adapt™ |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | M440SGP2000 | SGP200 | Synthetic Mineral Collagen Composite Bone Graft | StarGraft Putty | COLLAGEN MATRIX, INC. | |
2 | M440SGP1000 | SGP100 | Synthetic Mineral Collagen Composite Bone Graft | StarGraft Putty | COLLAGEN MATRIX, INC. | |
3 | M440SGP0500 | SGP050 | Synthetic Mineral Collagen Composite Bone Graft | StarGraft Putty | COLLAGEN MATRIX, INC. | |
4 | M440323100080 | 32310008 | Xenograft Granules Syringe, Particle Size 0.25 - 1.0mm | SYMBIOS | COLLAGEN MATRIX, INC. | |
5 | M440323100070 | 32310007 | Xenograft Granules Syringe, Particle Size 0.25 - 1.0mm | SYMBIOS | COLLAGEN MATRIX, INC. | |
6 | M440323100060 | 32310006 | Xenograft Granules Syringe, Particle Size 0.25 - 1.0mm | SYMBIOS | COLLAGEN MATRIX, INC. | |
7 | M440323100050 | 32310005 | Xenograft Granules, Particle Size 1.0-2.0mm | SYMBIOS | COLLAGEN MATRIX, INC. | |
8 | M440323100040 | 32310004 | Xenograft Granules, Particle Size 1.0-2.0mm | SYMBIOS | COLLAGEN MATRIX, INC. | |
9 | M440323100030 | 32310003 | Xenograft Granules, Particle Size 0.25-1.0mm | SYMBIOS | COLLAGEN MATRIX, INC. | |
10 | M440323100020 | 32310002 | Xenograft Granules, Particle Size 0.25-1.0mm | SYMBIOS | COLLAGEN MATRIX, INC. | |
11 | M440323100010 | 32310001 | Xenograft Granules, Particle Size 0.25-1.0mm | SYMBIOS | COLLAGEN MATRIX, INC. | |
12 | M440323100000 | 32310000 | Xenograft Granules, Particle Size 0.25-1.0mm | SYMBIOS | COLLAGEN MATRIX, INC. | |
13 | 08809490620918 | 25-1217 | OCTABONE | CHIYEWON.LTD | ||
14 | 08809490620901 | 05-1217 | OCTABONE | CHIYEWON.LTD | ||
15 | 08809490620895 | 10-1217 | OCTABONE | CHIYEWON.LTD | ||
16 | 08809490620888 | 20-1217 | OCTABONE | CHIYEWON.LTD | ||
17 | 08809490620871 | 20-0210 | OCTABONE | CHIYEWON.LTD | ||
18 | 08809490620864 | 10-0210 | OCTABONE | CHIYEWON.LTD | ||
19 | 08809490620857 | 05-0210 | OCTABONE | CHIYEWON.LTD | ||
20 | 08809490620840 | 25-0210 | OCTABONE | CHIYEWON.LTD | ||
21 | 08809490620567 | S05-1217 | TI-OSS | CHIYEWON.LTD | ||
22 | 08809490620550 | S25-1217 | TI-OSS | CHIYEWON.LTD | ||
23 | 08809490620505 | S05-0512 | TI-OSS | CHIYEWON.LTD | ||
24 | 08809490620499 | S25-0512 | TI-OSS | CHIYEWON.LTD | ||
25 | 08809490620444 | 20-1217 | TI-OSS | CHIYEWON.LTD | ||
26 | 08809490620437 | 10-1217 | TI-OSS | CHIYEWON.LTD | ||
27 | 08809490620420 | 05-1217 | TI-OSS | CHIYEWON.LTD | ||
28 | 08809490620413 | 25-1217 | TI-OSS | CHIYEWON.LTD | ||
29 | 08809490620291 | 20-0512 | TI-OSS | CHIYEWON.LTD | ||
30 | 08809490620284 | 10-0512 | TI-OSS | CHIYEWON.LTD | ||
31 | 08809490620277 | 05-0512 | TI-OSS | CHIYEWON.LTD | ||
32 | 08809490620260 | 25-0512 | TI-OSS | CHIYEWON.LTD | ||
33 | 08809490620147 | 20-0210 | TI-OSS | CHIYEWON.LTD | ||
34 | 08809490620130 | 10-0210 | TI-OSS | CHIYEWON.LTD | ||
35 | 08809490620123 | 05-0210 | TI-OSS | CHIYEWON.LTD | ||
36 | 08809490620116 | 25-0210 | TI-OSS | CHIYEWON.LTD | ||
37 | 08809186549516 | CB-0110-050 | OCS-B Collagen® is a combination of purified cancellous bone mineral granules (O OCS-B Collagen® is a combination of purified cancellous bone mineral granules (OCS-B®) and 10% collagen in a block form in a blister and cylindrical form in a syringe and blister. It is sterilized by γ- irradiation. | OCS-B Collagen | NIBEC CO., LTD. | |
38 | 08809186549509 | CB-0110-025 | OCS-B Collagen® is a combination of purified cancellous bone mineral granules (O OCS-B Collagen® is a combination of purified cancellous bone mineral granules (OCS-B®) and 10% collagen in a block form in a blister and cylindrical form in a syringe and blister. It is sterilized by γ- irradiation. | OCS-B Collagen | NIBEC CO., LTD. | |
39 | 08809186549493 | CB-0110-005 | OCS-B Collagen® is a combination of purified cancellous bone mineral granules (O OCS-B Collagen® is a combination of purified cancellous bone mineral granules (OCS-B®) and 10% collagen in a block form in a blister and cylindrical form in a syringe and blister. It is sterilized by γ- irradiation. | OCS-B Collagen | NIBEC CO., LTD. | |
40 | 08809186549455 | RSP2-L | Regenomer® is a sponge-like absorbable and porous collagen designed to be used a Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Regenomer® is manufactured in three types, Regenomer® Syringe (sheet shape in syringe and blister), Regenomer® Plug (bullet shape in blister), and Regenomer® Block (block shape in blister). Regenomer® are supplied sterile, non-pyrogenic, and for single use only. | Regenomer | NIBEC CO., LTD. | |
41 | 08809186549448 | RSP1-S | Regenomer® is a sponge-like absorbable and porous collagen designed to be used a Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Regenomer® is manufactured in three types, Regenomer® Syringe (sheet shape in syringe and blister), Regenomer® Plug (bullet shape in blister), and Regenomer® Block (block shape in blister). Regenomer® are supplied sterile, non-pyrogenic, and for single use only. | Regenomer | NIBEC CO., LTD. | |
42 | 08809186549431 | RSB2-L | Regenomer® is a sponge-like absorbable and porous collagen designed to be used a Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Regenomer® is manufactured in three types, Regenomer® Syringe (sheet shape in syringe and blister), Regenomer® Plug (bullet shape in blister), and Regenomer® Block (block shape in blister). Regenomer® are supplied sterile, non-pyrogenic, and for single use only. | Regenomer | NIBEC CO., LTD. | |
43 | 08809186549424 | RSB1-S | Regenomer® is a sponge-like absorbable and porous collagen designed to be used a Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Regenomer® is manufactured in three types, Regenomer® Syringe (sheet shape in syringe and blister), Regenomer® Plug (bullet shape in blister), and Regenomer® Block (block shape in blister). Regenomer® are supplied sterile, non-pyrogenic, and for single use only. | Regenomer | NIBEC CO., LTD. | |
44 | 08809186549349 | CB-0110-010 | OCS-B Collagen® is a combination of purified cancellous bone mineral granules (O OCS-B Collagen® is a combination of purified cancellous bone mineral granules (OCS-B®) and 10% collagen in a block form in a blister and cylindrical form in a syringe and blister. It is sterilized by γ- irradiation. | OCS-B Collagen | NIBEC CO., LTD. | |
45 | 08809186549332 | CB-0110-050S | OCS-B Collagen® is a combination of purified cancellous bone mineral granules (O OCS-B Collagen® is a combination of purified cancellous bone mineral granules (OCS-B®) and 10% collagen in a block form in a blister and cylindrical form in a syringe and blister. It is sterilized by γ- irradiation. | OCS-B Collagen | NIBEC CO., LTD. | |
46 | 08809186549325 | CB-0110-025S | OCS-B Collagen® is a combination of purified cancellous bone mineral granules (O OCS-B Collagen® is a combination of purified cancellous bone mineral granules (OCS-B®) and 10% collagen in a block form in a blister and cylindrical form in a syringe and blister. It is sterilized by γ- irradiation. | OCS-B Collagen | NIBEC CO., LTD. | |
47 | 08809186549127 | L1-1020-050 | The OCS-B OsteoConductive Substitute-Bovine bone grafting material is a sterile, The OCS-B OsteoConductive Substitute-Bovine bone grafting material is a sterile, porous bone mineral matrix produced by the removal of the organic compounds from bovine bone. The OCS-B contains pure hydroxyapatite derived from bovine bone using a validated the manufacturing process. The large surface area of OCS-B is effective for the regeneration of new bone around the grafted bone. The OCS-B has good osteoconductivity to enhance new bone formation. The OCS-Bs are supplied as cancellous (spongiosa) or cortical granules in single-use containers. | OCS-B | NIBEC CO., LTD. | |
48 | 08809186549110 | L1-1020-025 | The OCS-B OsteoConductive Substitute-Bovine bone grafting material is a sterile, The OCS-B OsteoConductive Substitute-Bovine bone grafting material is a sterile, porous bone mineral matrix produced by the removal of the organic compounds from bovine bone. The OCS-B contains pure hydroxyapatite derived from bovine bone using a validated the manufacturing process. The large surface area of OCS-B is effective for the regeneration of new bone around the grafted bone. The OCS-B has good osteoconductivity to enhance new bone formation. The OCS-Bs are supplied as cancellous (spongiosa) or cortical granules in single-use containers. | OCS-B | NIBEC CO., LTD. | |
49 | 08809186549080 | L1-0210-050 | The OCS-B OsteoConductive Substitute-Bovine bone grafting material is a sterile, The OCS-B OsteoConductive Substitute-Bovine bone grafting material is a sterile, porous bone mineral matrix produced by the removal of the organic compounds from bovine bone. The OCS-B contains pure hydroxyapatite derived from bovine bone using a validated the manufacturing process. The large surface area of OCS-B is effective for the regeneration of new bone around the grafted bone. The OCS-B has good osteoconductivity to enhance new bone formation. The OCS-Bs are supplied as cancellous (spongiosa) or cortical granules in single-use containers. | OCS-B | NIBEC CO., LTD. | |
50 | 08809186549073 | L1-0210-025 | The OCS-B OsteoConductive Substitute-Bovine bone grafting material is a sterile, The OCS-B OsteoConductive Substitute-Bovine bone grafting material is a sterile, porous bone mineral matrix produced by the removal of the organic compounds from bovine bone. The OCS-B contains pure hydroxyapatite derived from bovine bone using a validated the manufacturing process. The large surface area of OCS-B is effective for the regeneration of new bone around the grafted bone. The OCS-B has good osteoconductivity to enhance new bone formation. The OCS-Bs are supplied as cancellous (spongiosa) or cortical granules in single-use containers. | OCS-B | NIBEC CO., LTD. |