| Primary Device ID | 00850001118125 |
| NIH Device Record Key | 1b3a1e38-1c40-4a9c-80da-cbca3a262c9d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GEM™ Bone Graft |
| Version Model Number | LBNB1020 |
| Company DUNS | 079604282 |
| Company Name | LYNCH BIOLOGICS, LLC |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850001118125 [Primary] |
| NPM | Bone Grafting Material, Animal Source |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-11-19 |
| Device Publish Date | 2018-10-18 |
| 00850001118156 | Osteoconductive Bone Matrix in Syringe, 0.5cc (Particle Size 0.25-1.0mm) |
| 00850001118149 | Osteoconductive Bone Matrix in Syringe, 0.25cc (Particle Size 0.25-1.0mm) |
| 00850001118132 | Osteoconductive Bone Matrix, 2.0cc (Particle Size 1.0-2.0mm) |
| 00850001118125 | Osteoconductive Bone Matrix, 1.0cc (Particle Size 1.0-2.0mm) |
| 00850001118118 | Osteoconductive Bone Matrix, 4.0cc (Particle Size 0.25-1.0mm) |
| 00850001118101 | Osteoconductive Bone Matrix, 2.0cc (Particle Size 0.25-1.0mm) |
| 00850001118095 | Osteoconductive Bone Matrix, 1.0cc (Particle Size 0.25-1.0mm) |
| 00850001118088 | Osteoconductive Bone Matrix, 0.5cc (Particle Size 0.25-1.0mm) |