No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 04560245656975 | AR-13372-3 | AR-13372-3 | 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 |
2 | 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 |
3 | 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 |
4 | 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 |
5 | 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 |
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 | 00850009685193 | CBA-1600 | Moldable Bone Graft Matrix | contour BA | COLLAGEN MATRIX, INC. | |
2 | 00850009685186 | CBA-800 | Moldable Bone Graft Matrix | contour BA | COLLAGEN MATRIX, INC. | |
3 | 00850009685179 | CBA-400 | Moldable Bone Graft Matrix | contour BA | COLLAGEN MATRIX, INC. | |
4 | 00850009685162 | CBA-1000 | Moldable Bone Graft Matrix | contour BA | COLLAGEN MATRIX, INC. | |
5 | 00850009685155 | CBA-500 | Moldable Bone Graft Matrix | contour BA | COLLAGEN MATRIX, INC. | |
6 | 00850009685148 | CBA-200 | Moldable Bone Graft Matrix | contour BA | COLLAGEN MATRIX, INC. | |
7 | 00850005961109 | CF-s25x75x3 | CF-s25x75x3 | CellFUSE Sheet 25mm x 75mm x 3mm | CellFUSE | REGENACELL THERAPY INC |
8 | 00850005961093 | CF-s25x50x3 | CF-s25x50x3 | CellFUSE Sheet 25mm x 50mm x 3mm | CellFUSE | REGENACELL THERAPY INC |
9 | 00850005961086 | CF-s25x25x3 | CF-s25x25x3 | CellFUSE Sheet 25mm x 25mm x 3mm | CellFUSE | REGENACELL THERAPY INC |
10 | 00850005961079 | CF-G30 | CF-G30 | CellFUSE™ Granules 30cc | CellFUSE™ | REGENACELL THERAPY INC |
11 | 00850005961062 | CF-G20 | CF-G20 | CellFUSE™ Granules 20cc | CellFUSE™ | REGENACELL THERAPY INC |
12 | 00850005961055 | CF-G10 | CF-G10 | CellFUSE™ Granules 10cc | CellFUSE™ | REGENACELL THERAPY INC |
13 | 00850005961048 | CF-G5 | CF-G5 | CellFUSE™ Granules 5cc | CellFUSE™ | REGENACELL THERAPY INC |
14 | 00850005961031 | CF-s25x125x5 | CF-s25x125x5 | CellFUSE™ Sheet 25mm x 125mm x 5mm | CellFUSE™ | REGENACELL THERAPY INC |
15 | 00850005961024 | CF-s25x75x5 | CF-s25x75x5 | CellFUSE™ Sheet 25mm x 75mm x 5mm | CellFUSE™ | REGENACELL THERAPY INC |
16 | 00850005961017 | CF-s25x50x5 | CF-s25x50x5 | CellFUSE™ Sheet 25mm x 50mm x 5mm | CellFUSE™ | REGENACELL THERAPY INC |
17 | 00850005961000 | CF-s25x25x5 | CF-s25x25x5 | CellFUSE™ Sheet 25mm x 25mm x 5mm | CellFUSE™ | REGENACELL THERAPY INC |
18 | 00850001375047 | BFBA-4000 | Moldable Bone Graft Matrix | BiFORM Bioactive Moldable | COLLAGEN MATRIX, INC. | |
19 | 00850001375030 | BFBA-2000 | Moldable Bone Graft Matrix | BiFORM Bioactive Moldable | COLLAGEN MATRIX, INC. | |
20 | 00850001375023 | BFBA-1000 | Moldable Bone Graft Matrix | BiFORM Bioactive Moldable | COLLAGEN MATRIX, INC. | |
21 | 00850001375016 | BFBA-0500 | Moldable Bone Graft Matrix | BiFORM Bioactive Moldable | COLLAGEN MATRIX, INC. | |
22 | 00850001375009 | BFBA-0250 | Moldable Bone Graft Matrix | BiFORM Bioactive Moldable | COLLAGEN MATRIX, INC. | |
23 | 00849777012126 | LD-600-050-M | ONE (1) PACKAGE - CONTAINING 5.0cc (jar) | DBM Putty 5.0cc | XTANT MEDICAL HOLDINGS, INC. | |
24 | 00849777011976 | C024-0001-PTYV | ONE (1) PACKAGE - CONTAINING 1.0cc | CuriGraft DBM Putty, 1cc | XTANT MEDICAL HOLDINGS, INC. | |
25 | 00849777011969 | C024-0025-PTYV | ONE (1) PACKAGE - CONTAINING 2.5cc | CuriGraft DBM Putty, 2.5cc | XTANT MEDICAL HOLDINGS, INC. | |
26 | 00849777011952 | C024-0005-PTYV | ONE (1) PACKAGE - CONTAINING 5.0cc | CuriGraft DBM Putty, 5cc | XTANT MEDICAL HOLDINGS, INC. | |
27 | 00849777011945 | C024-0010-PTYV | ONE (1) PACKAGE - CONTAINING 10.0cc | CuriGraft DBM Putty, 10cc | XTANT MEDICAL HOLDINGS, INC. | |
28 | 00849777011938 | IFLX-CR-10 | ONE (1) PACKAGE - CONTAINING 10.0cc | Influx Plus Crunch 10.0cc - Syringe | XTANT MEDICAL HOLDINGS, INC. | |
29 | 00849777011921 | IFLX-CR-05 | ONE (1) PACKAGE - CONTAINING 5.0cc | Influx Plus Crunch 5.0cc - Syringe | XTANT MEDICAL HOLDINGS, INC. | |
30 | 00849777011914 | IFLX-CR-02 | ONE (1) PACKAGE - CONTAINING 2.5cc | Influx Plus Crunch 2.5cc - Syringe | XTANT MEDICAL HOLDINGS, INC. | |
31 | 00849777011907 | IFLX-FW-10 | ONE (1) PACKAGE - CONTAINING 10.0cc | Influx Plus Flow 10.0cc - Syringe | XTANT MEDICAL HOLDINGS, INC. | |
32 | 00849777011891 | IFLX-FW-05 | ONE (1) PACKAGE - CONTAINING 5.0cc | Influx Plus Flow 5.0cc - Syringe | XTANT MEDICAL HOLDINGS, INC. | |
33 | 00849777011884 | IFLX-FW-02 | ONE (1) PACKAGE - CONTAINING 2.5cc | Influx Plus Flow 2.5cc - Syringe | XTANT MEDICAL HOLDINGS, INC. | |
34 | 00849777011877 | IFLX-FW-01 | ONE (1) PACKAGE - CONTAINING 1.0cc | Influx Plus Flow 1.0cc - Syringe | XTANT MEDICAL HOLDINGS, INC. | |
35 | 00849777011792 | OM-PUT01P | ONE (1) PACKAGE - CONTAINING 1.0cc | Demineralized Bone Matrix, 1cc | XTANT MEDICAL HOLDINGS, INC. | |
36 | 00849777011785 | OM-PUT05P | ONE (1) PACKAGE - CONTAINING 5.0cc | Demineralized Bone Matrix, 5cc | XTANT MEDICAL HOLDINGS, INC. | |
37 | 00849777011778 | OM-PUT10P | ONE (1) PACKAGE - CONTAINING 10.0cc | Demineralized Bone Matrix, 10cc | XTANT MEDICAL HOLDINGS, INC. | |
38 | 00849777011761 | MFC-10 | ONE (1) PACKAGE - CONTAINING 10.0cc | MAXX™ Fuse DBM Putty with Chips 10cc | XTANT MEDICAL HOLDINGS, INC. | |
39 | 00849777011754 | MFC-5 | ONE (1) PACKAGE - CONTAINING 5.0cc | MAXX™ Fuse DBM Putty with Chips 5cc | XTANT MEDICAL HOLDINGS, INC. | |
40 | 00849777011747 | MFC-2 | ONE (1) PACKAGE - CONTAINING 2.5cc | MAXX™ Fuse DBM Putty with Chips, 2.5cc | XTANT MEDICAL HOLDINGS, INC. | |
41 | 00849777011730 | DBM001 | ONE (1) PACKAGE - CONTAINING 1.0cc | VIA DBM Putty, 1cc | XTANT MEDICAL HOLDINGS, INC. | |
42 | 00849777011723 | DBM0025 | ONE (1) PACKAGE - CONTAINING 2.5cc | VIA DBM Putty, 2.5cc | XTANT MEDICAL HOLDINGS, INC. | |
43 | 00849777011716 | DBM002 | ONE (1) PACKAGE - CONTAINING 2.0cc | VIA DBM Putty, 2cc | XTANT MEDICAL HOLDINGS, INC. | |
44 | 00849777011709 | DBM005 | ONE (1) PACKAGE - CONTAINING 5.0cc | VIA DBM Putty, 5cc | XTANT MEDICAL HOLDINGS, INC. | |
45 | 00849777011693 | DBM010 | ONE (1) PACKAGE - CONTAINING 10.0cc | VIA DBM Putty, 10cc | XTANT MEDICAL HOLDINGS, INC. | |
46 | 00849777011686 | VX-EP3 | ONE (1) PACKAGE - CONTAINING 3.0cc | VIA DBM Plus, 3cc | XTANT MEDICAL HOLDINGS, INC. | |
47 | 00849777011679 | VX-EP5 | ONE (1) PACKAGE - CONTAINING 5.0cc | VIA DBM Plus, 5cc | XTANT MEDICAL HOLDINGS, INC. | |
48 | 00849777011662 | VX-EP10 | ONE (1) PACKAGE - CONTAINING 10.0cc | VIA DBM Plus, 10cc | XTANT MEDICAL HOLDINGS, INC. | |
49 | 00849777011617 | 27803518 | ONE (1) PACKAGE - CONTAINING 0.5cc | Reficio DBM Putty 0.5cc | XTANT MEDICAL HOLDINGS, INC. | |
50 | 00849777011594 | X055-0055 | 10.0cc (Syringe) | DBM Putty 10.0cc - Syringe | XTANT MEDICAL HOLDINGS, INC. |