| Primary Device ID | 00812444028430 |
| NIH Device Record Key | 94d7fe81-89c0-4d0d-b2a8-574e70f4ceda |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Colink Adjustable Loop |
| Version Model Number | TEK-OBAL-80 |
| Company DUNS | 964053560 |
| Company Name | RIVERPOINT MEDICAL, 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812444028430 [Primary] |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-03-21 |
| Device Publish Date | 2018-07-05 |
| 00840277409980 - SmartLoop Tape | 2025-09-29 Suture |
| 00840277409997 - SmartLoop Tape | 2025-09-29 Suture |
| 00840277410009 - SmartLoop Tape | 2025-09-29 Suture |
| 00840277410160 - ARTHROLINK | 2025-09-29 Suture |
| 00840277410177 - ARTHROLINK | 2025-09-29 Suture |
| 00840277410184 - ARTHROLINK | 2025-09-29 Suture |
| 00840277410191 - ARTHROLINK | 2025-09-29 Suture |
| 00840277410207 - ARTHROLINK | 2025-09-29 Suture |