| 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 |
| 00840277405579 - RootMend™ MRR (Black) | 2025-05-09 Adjustable Loop |
| 00840277405586 - RootMend™ MRR (Blue) | 2025-05-09 Adjustable Loop |
| 00840277405593 - RootMend™ MRR | 2025-05-09 Titanium Button |
| 00840277405647 - RootMend™ MRR Soft Button (Black) | 2025-05-09 Adjustable Loop |
| 00840277405654 - RootMend™ MRR Soft Button (Blue) | 2025-05-09 Adjustable Loop |
| 00840277402196 - PERMACORD™ Stiffened Suture | 2025-05-06 Size 2 Stiffened Suture Blue, UHMWPE Non-absorbable Suture |
| 00840277402219 - PERMACORD™ Stiffened Suture | 2025-05-06 Size 2 Stiffened Suture White/Blue, UHMWPE Non-absorbable Suture |
| 00840277402233 - PERMALOOP™ MINI Stiffened Suture | 2025-05-06 1.4mm Stiffened Suture Tape w/ Looped End Blue, UHMWPE Non-absorbable Suture |