| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 04560245656968 | AR-13372-2 | AR-13372-2 | OSferion is a white porous material composed of β-tricalciumphosphate. It is int OSferion is a white porous material composed of β-tricalciumphosphate. It is intended to fill bony voids or gaps caused bytrauma or surgery that are not intrinsic to the stability of thebony structure. OSferion is to be used as a bone replacementmaterial and has properties that allow it to be replaced byautogenous bone after implantation.The porosity of OSferion is 60%.Products are supplied in wedges and trapezoids. | MQV | Filler, Bone Void, Calcium Compound | 2 | OSferion |
| 2 | 04560245656951 | AR-13372-1 | AR-13372-1 | OSferion is a white porous material composed of β-tricalciumphosphate. It is int OSferion is a white porous material composed of β-tricalciumphosphate. It is intended to fill bony voids or gaps caused bytrauma or surgery that are not intrinsic to the stability of thebony structure. OSferion is to be used as a bone replacementmaterial and has properties that allow it to be replaced byautogenous bone after implantation.The porosity of OSferion is 60%.Products are supplied in wedges and trapezoids. | MQV | Filler, Bone Void, Calcium Compound | 2 | OSferion |
| 3 | 04560245656913 | AR-13370-4 | AR-13370-4 | OSferion is a white porous material composed of β-tricalciumphosphate. It is int OSferion is a white porous material composed of β-tricalciumphosphate. It is intended to fill bony voids or gaps caused bytrauma or surgery that are not intrinsic to the stability of thebony structure. OSferion is to be used as a bone replacementmaterial and has properties that allow it to be replaced byautogenous bone after implantation.The porosity of OSferion is 60%.Products are supplied in wedges and trapezoids. | MQV | Filler, Bone Void, Calcium Compound | 2 | OSferion |
| 4 | 04560245656906 | AR-13370-3 | AR-13370-3 | OSferion is a white porous material composed of β-tricalciumphosphate. It is int OSferion is a white porous material composed of β-tricalciumphosphate. It is intended to fill bony voids or gaps caused bytrauma or surgery that are not intrinsic to the stability of thebony structure. OSferion is to be used as a bone replacementmaterial and has properties that allow it to be replaced byautogenous bone after implantation.The porosity of OSferion is 60%.Products are supplied in wedges and trapezoids. | MQV | Filler, Bone Void, Calcium Compound | 2 | OSferion |
| 5 | 04560245656890 | AR-13370-2 | AR-13370-2 | OSferion is a white porous material composed of β-tricalciumphosphate. It is int OSferion is a white porous material composed of β-tricalciumphosphate. It is intended to fill bony voids or gaps caused bytrauma or surgery that are not intrinsic to the stability of thebony structure. OSferion is to be used as a bone replacementmaterial and has properties that allow it to be replaced byautogenous bone after implantation.The porosity of OSferion is 60%.Products are supplied in wedges and trapezoids. | MQV | Filler, Bone Void, Calcium Compound | 2 | OSferion |
| 6 | 04560245656883 | AR-13370-1 | AR-13370-1 | OSferion is a white porous material composed of β-tricalciumphosphate. It is int OSferion is a white porous material composed of β-tricalciumphosphate. It is intended to fill bony voids or gaps caused bytrauma or surgery that are not intrinsic to the stability of thebony structure. OSferion is to be used as a bone replacementmaterial and has properties that allow it to be replaced byautogenous bone after implantation.The porosity of OSferion is 60%.Products are supplied in wedges and trapezoids. | MQV | Filler, Bone Void, Calcium Compound | 2 | OSferion |
| 7 | 04560245656821 | 27-500-100 | 27-500-100 | Collagen-Based Bone Filling Augmentation Material./Product Overview:FOUNDATION i Collagen-Based Bone Filling Augmentation Material./Product Overview:FOUNDATION is made of absorbable atelo-collagen. Theatelo-collagen has been cross-linked by heat treatmentin order to achieve biocompatibility. FOUNDATION isprovided in bullet shapes. The collagen (liquid form)suspension is pored into a bullet shape mold. The designof the bullet shape is to permit easy placement into theextraction socket. It consists of fibrillar and heat-denaturedatelo-collagen. Fibrillar atelo-collagen provides scaffoldingfor surrounding cells and the heat-denatured atelo-collagenstimulates infiltration of the cells in the product. Contents are sterile and non-pyrogenic. | LYC | Bone Grafting Material, Synthetic | 2 | Foundation® |
| 8 | 04560245656814 | 27-500-200 | 27-500-200 | Collagen-Based Bone Filling Augmentation Material./Product Overview:FOUNDATION i Collagen-Based Bone Filling Augmentation Material./Product Overview:FOUNDATION is made of absorbable atelo-collagen. Theatelo-collagen has been cross-linked by heat treatmentin order to achieve biocompatibility. FOUNDATION isprovided in bullet shapes. The collagen (liquid form)suspension is pored into a bullet shape mold. The designof the bullet shape is to permit easy placement into theextraction socket. It consists of fibrillar and heat-denaturedatelo-collagen. Fibrillar atelo-collagen provides scaffoldingfor surrounding cells and the heat-denatured atelo-collagenstimulates infiltration of the cells in the product. Contents are sterile and non-pyrogenic. | LYC | Bone Grafting Material, Synthetic | 2 | Foundation® |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 06953122702304 | Gr-3 | Particles | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 2 | 06953122702298 | Gr-2 | Particles | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 3 | 06953122702281 | Gr-1 | Particles | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 4 | 06953122702274 | Re-7 | Block | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 5 | 06953122702267 | Re-6 | Block | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 6 | 06953122702250 | Re-5 | Block | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 7 | 06953122702243 | Re-4 | Block | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 8 | 06953122702236 | Re-3 | Block | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 9 | 06953122702212 | Re-2 | Block | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 10 | 06953122702205 | Re-1 | Block | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 11 | 06953122702199 | Co-5 | Cylinder | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 12 | 06953122702182 | Co-4 | Cylinder | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 13 | 06953122702175 | Co-3 | Cylinder | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 14 | 06953122702168 | Co-2 | Cylinder | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 15 | 06953122702151 | Co-1 | Cylinder | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
| 16 | 06438408009730 | 1 | SGN-1500 | Morsels 1.5 cc / 1.5 ml | Ventris SIgnal™ | INION OY |
| 17 | 06438408009617 | 1 | BRS-1602 | Block 5 x 10 x 4 mm | Inion OTPS BioRestore™ | INION OY |
| 18 | 06438408009587 | 1 | BRS-5497 | Block, Large, Wedge 14 mm | Inion BioRestore™ Sahara | INION OY |
| 19 | 06438408009570 | 1 | BRS-5496 | Block, Large, Wedge 12 mm | Inion BioRestore™ Sahara | INION OY |
| 20 | 06438408009563 | 1 | BRS-5495 | Block, Large, Wedge 10 mm | Inion BioRestore™ Sahara | INION OY |
| 21 | 06438408009556 | 1 | BRS-5494 | Block, Large, Wedge 8 mm | Inion BioRestore™ Sahara | INION OY |
| 22 | 06438408009549 | 1 | BRS-5493 | Block, Large 14 mm | Inion BioRestore™ Sahara | INION OY |
| 23 | 06438408009532 | 1 | BRS-5492 | Block, Large 12 mm | Inion BioRestore™ Sahara | INION OY |
| 24 | 06438408009525 | 1 | BRS-5491 | Block, Large 10 mm | Inion BioRestore™ Sahara | INION OY |
| 25 | 06438408009518 | 1 | BRS-5490 | Block, Large 8 mm | Inion BioRestore™ Sahara | INION OY |
| 26 | 06438408009501 | 1 | BRS-5487 | Block, Standard, Wedge 14 mm | Inion BioRestore™ Sahara | INION OY |
| 27 | 06438408009495 | 1 | BRS-5486 | Block, Standard, Wedge 12 mm | Inion BioRestore™ Sahara | INION OY |
| 28 | 06438408009488 | 1 | BRS-5485 | Block, Standard, Wedge 10 mm | Inion BioRestore™ Sahara | INION OY |
| 29 | 06438408009471 | 1 | BRS-5484 | Block, Standard, Wedge 8 mm | Inion BioRestore™ Sahara | INION OY |
| 30 | 06438408009464 | 1 | BRS-5483 | Block, Standard 14 mm | Inion BioRestore™ Sahara | INION OY |
| 31 | 06438408009419 | 1 | BRS-5473 | Oval, Standard 7 mm | Inion BioRestore™ Sahara | INION OY |
| 32 | 06438408009402 | 1 | BRS-5472 | Oval, Standard 6 mm | Inion BioRestore™ Sahara | INION OY |
| 33 | 06438408009396 | 1 | BRS-5471 | Oval, Standard 5 mm | Inion BioRestore™ Sahara | INION OY |
| 34 | 06438408009389 | 1 | BRS-5470 | Oval, Standard 4 mm | Inion BioRestore™ Sahara | INION OY |
| 35 | 06438408009372 | 1 | BRS-5464 | Oval, Small 8 mm | Inion BioRestore™ Sahara | INION OY |
| 36 | 06438408009365 | 1 | BRS-5463 | Oval, Small 7 mm | Inion BioRestore™ Sahara | INION OY |
| 37 | 06438408009358 | 1 | BRS-5462 | Oval, Small 6 mm | Inion BioRestore™ Sahara | INION OY |
| 38 | 06438408009341 | 1 | BRS-5461 | Oval, Small 5 mm | Inion BioRestore™ Sahara | INION OY |
| 39 | 06438408009327 | 1 | BRS-5450 | Cylinder 8 x 15 mm | Inion BioRestore™ | INION OY |
| 40 | 06438408009310 | 1 | BRS-5443 | Block 60 x 40 x 8 mm | Inion BioRestore™ | INION OY |
| 41 | 06438408009303 | 1 | BRS-5442 | Block 30 x 20 x 8 mm | Inion BioRestore™ | INION OY |
| 42 | 06438408009297 | 1 | BRS-5441 | Block 15 x 25 x 4 mm | Inion BioRestore™ | INION OY |
| 43 | 06438408009280 | 1 | BRS-5440 | Block 5 x 10 x 4 mm | Inion BioRestore™ | INION OY |
| 44 | 06438408009273 | 1 | BRS-5429 | Block, Wedge 13 mm | Inion BioRestore™ | INION OY |
| 45 | 06438408009266 | 1 | BRS-5420 | Block, Wedge 4 mm | Inion BioRestore™ | INION OY |
| 46 | 06438408009259 | 1 | BRS-5409 | Block, Gradient 13 mm | Inion BioRestore™ | INION OY |
| 47 | 06438408009242 | 1 | BRS-5400 | Block, Gradient 4 mm | Inion BioRestore™ | INION OY |
| 48 | 06438408009198 | 1 | BRS-5433 | Morsels 10 cc, in syringe | Inion BioRestore™ | INION OY |
| 49 | 06438408009181 | 1 | BRS-5447 | Morsels 8 cc, in syringe | Inion BioRestore™ | INION OY |
| 50 | 06438408009174 | 1 | BRS-5446 | Morsels 6 cc, in syringe | Inion BioRestore™ | INION OY |