| Primary Device ID | 00810021864242 |
| NIH Device Record Key | 193e5311-f02d-4fbe-884c-91431ba73a10 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CoLink Afx |
| Version Model Number | P07 S0001 |
| Catalog Number | P07 S0001 |
| Company DUNS | 079700711 |
| Company Name | IN2BONES USA, 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 | true |
| 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 | 00810021864242 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-01-03 |
| Device Publish Date | 2024-12-10 |
| 00810021864020 | CoLink Afx Washer, 3.5/4.0 |
| 00810021864242 | CoLink Afx Sterile Single Use Instrument Kit |