Primary Device ID | 03700501812818 |
NIH Device Record Key | 79f5fdea-da7d-4239-9571-22f006cb54ff |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | RESORBA Synthetic Bone |
Version Model Number | SB9902G02 |
Catalog Number | SB9902G02 |
Company DUNS | 493710719 |
Company Name | BIOMATLANTE |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 03700501812818 [Primary] |
LYC | Bone Grafting Material, Synthetic |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-06-18 |
Device Publish Date | 2021-06-10 |
03700501813280 | Synthetic Bone Substitute Cylinder Diam 14mm, Height 20mm |
03700501813273 | Synthetic Bone Substitute Cylinder Diam 10mm, Height 20mm |
03700501813266 | Synthetic Bone Substitute Cylinder Diam 12mm, Height 20mm |
03700501813259 | Synthetic Bone Substitute Wedge base 8mm (x1) |
03700501813242 | Synthetic Bone Substitute Wedge base 10mm (x1) |
03700501813235 | Synthetic Bone Substitute Wedge base 12mm (x1) |
03700501813228 | Synthetic Bone Substitute Cylinder Diam 8mm, Height 20mm |
03700501813211 | Synthetic Bone Substitute Cylinder Diam 9.5mm, Height 20mm |
03700501813136 | Synthetic Bone Substitute Wedge base 6mm (x1) |
03700501813129 | Synthetic Bone Substitute Wedge base 5mm (x1) |
03700501813112 | Synthetic Bone Substitute Granules 2-3mm (16cc) |
03700501813105 | Synthetic Bone Substitute Granules 2-3mm (2cc) |
03700501813099 | Synthetic Bone Substitute Sticks 5x5x20mm (x4) |
03700501813082 | Synthetic Bone Substitute Sticks 5x5x20mm (x2) |
03700501813075 | Synthetic Bone Substitute Sticks 5x5x10mm (x4) |
03700501813068 | Synthetic Bone Substitute Sticks 5x5x10mm (x2) |
03700501813037 | Synthetic Bone Substitute Rounded wedge 14mm (x1) |
03700501813020 | Synthetic Bone Substitute Granules 1-2mm syringe (10cc) |
03700501813013 | Synthetic Bone Substitute Granules 1-2mm syringe (5cc) |
03700501813006 | Synthetic Bone Substitute Stick 10x10x40mm (x1) |
03700501812993 | Synthetic Bone Substitute Stick 10x20x50mm (x1) |
03700501812986 | Synthetic Bone Substitute Stick 10x30x30mm (x1) |
03700501812979 | Synthetic Bone Substitute Stick 12x25x25mm (x1) |
03700501812962 | Synthetic Bone Substitute Stick 10x10x10mm (x1) |
03700501812955 | Synthetic Bone Substitute Granules 2-3mm (20cc) |
03700501812948 | Synthetic Bone Substitute Granules 2-3mm (30cc) |
03700501812931 | Synthetic Bone Substitute Granules 1-2mm (30cc) |
03700501812924 | Synthetic Bone Substitute Rounded wedge 12mm (x1) |
03700501812917 | Synthetic Bone Substitute Rounded wedge 10mm (x1) |
03700501812900 | Synthetic Bone Substitute Rounded wedge 8mm (x1) |
03700501812894 | Synthetic Bone Substitute Rounded wedge 6mm (x1) |
03700501812856 | Synthetic Bone Substitute Granules 2-3mm (10cc) |
03700501812849 | Synthetic Bone Substitute Granules 1-2mm (10cc) |
03700501812832 | Synthetic Bone Substitute Granules 1-2mm (5cc) |
03700501812825 | Synthetic Bone Substitute Granules 2-3mm (5cc) |
03700501812818 | Synthetic Bone Substitute Granules 1-2mm (2cc) |
03700501812801 | Synthetic Bone Substitute Granules 0.5-1mm (0.5cc) |
03700501812795 | Synthetic Bone Substitute Granules 0.5-1mm (0.5cc) |
03700501812788 | Synthetic Bone Substitute Granules 0.5-1mm (1cc) |