| 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 |
| 00840277402721 - MedLED Spectra | 2024-05-07 Charger Wall Set (INT'L) |
| 00840277403193 - MedLED Spectra | 2024-05-07 Charger 4-Bay Set (US) |
| 00840277403551 - MedLED Chrome | 2024-05-07 Padding Set (2 pc.) |
| 00840277403650 - MedLED Face Shield | 2024-05-07 Shield and Mounting Kit |
| 00840277403667 - MedLED Face Shield | 2024-05-07 Shield & Mounting Kit; Low Notch Blank |
| 00840277403674 - MedLED Face Shield | 2024-05-07 Shield & Mounting Kit; Low Notch MedLED |
| 00840277403681 - MedLED Face Shield | 2024-05-07 Shield & Mounting Kit; Low Notch KLS |
| 00840277403698 - MedLED Face Shield | 2024-05-07 Shield & Mounting Kit; Low Notch Salvin |