| Primary Device ID | 00810021864020 |
| NIH Device Record Key | 699504d8-c8f2-4286-952e-383aa8ec87aa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CoLink Afx |
| Version Model Number | P42 ST031 |
| Company DUNS | 079700711 |
| Company Name | IN2BONES USA, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 | 00810021864020 [Primary] |
| HTN | Washer, Bolt Nut |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-14 |
| Device Publish Date | 2020-09-04 |
| 00810021864020 | CoLink Afx Washer, 3.5/4.0 |
| 00810021864242 | CoLink Afx Sterile Single Use Instrument Kit |