| Primary Device ID | 00812444028409 |
| NIH Device Record Key | d9b73b90-38c9-4f49-b6ec-ebed6884a576 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Colink Standard CL |
| Version Model Number | TEK-OBCL-35 |
| 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 | 00812444028409 [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 |
| 00812444028577 | Suture Button Loop |
| 00812444028560 | Suture Button Loop |
| 00812444028553 | Suture Button Loop |
| 00812444028546 | Suture Button Loop |
| 00812444028539 | Suture Button Loop |
| 00812444028522 | Suture Button Loop |
| 00812444028515 | Suture Button Loop |
| 00812444028508 | Suture Button Loop |
| 00812444028416 | Does not contain |
| 00812444028409 | Suture Button Loop |
| 00812444028850 | Suture button loop |