| Primary Device ID | 10818614020102 |
| NIH Device Record Key | 08bcab53-0d42-474a-9d4f-de0f3f70ae1f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SplitStitch |
| Version Model Number | HS138 |
| 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 | 00818614020105 [Primary] |
| GS1 | 10818614020102 [Package] Contains: 00818614020105 Package: [12 Units] In Commercial Distribution |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-03-12 |
| Device Publish Date | 2020-03-04 |
| 00840277411068 - HS Fiber | 2026-02-03 Suture |
| 00840277411396 - HS Fiber | 2026-01-21 Blue/White UHMWPE Polyblend Braided Non-Absorbable Suture Tape |
| 10840277411409 - HS Fiber | 2026-01-21 White/Blue UHMWPE polyblend braided non-absorbable suture. |
| 00840277410023 - ProZip Knotless Implant | 2026-01-14 ProZip Knotless Implant |
| 00840277410030 - ProZip Knotless Implant | 2026-01-14 ProZip Knotless Implant |
| 10840277410068 - ProZip Knotless Implant | 2026-01-14 ProZip Knotless Implant |
| 10840277410075 - ProZip Knotless Implant | 2026-01-14 ProZip Knotless Implant |
| 00840277411365 - ApeLoop | 2025-12-17 Suture |