| Primary Device ID | 00850005827276 |
| NIH Device Record Key | 0f64e517-c94a-4b97-a608-594c7e636b4a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GENESIS HYBRID KNOTLESS DUAL THREAD ANCHOR |
| Version Model Number | 10KPN4751 |
| Catalog Number | 10KPN4751 |
| Company DUNS | 016463487 |
| Company Name | Genesis Biologics, Inc. |
| 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 | 00850005827276 [Primary] |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-24 |
| Device Publish Date | 2023-03-16 |
| 00850005827283 | 5.5MM HYBRID KNOTLESS DUAL THREAD ANCHOR |
| 00850005827276 | 4.75MM HYBRID KNOTLESS DUAL THREAD ANCHOR |