| Primary Device ID | 00854037007088 |
| NIH Device Record Key | 528e2e8c-94db-4d3d-b36f-e72136bf4d6f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | eXact Suture 3-0 PTFE |
| Version Model Number | CM7230 |
| Company DUNS | 117322746 |
| Company Name | Cypris Medical, Inc. |
| 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 | 00854037007088 [Primary] |
| NBY | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-10 |
| Device Publish Date | 2024-04-02 |
| 00854037007170 - eXact Suture Placement Device | 2024-06-18 |
| 00854037007026 - eXact Suture 4-0 PP | 2024-04-10 eXact Suture, 4-0 Polypropylene |
| 00854037007040 - eXact Suture 3-0 PP | 2024-04-10 eXact Suture, 3-0 Polypropylene |
| 00854037007064 - eXact Suture 2-0 PTFE | 2024-04-10 eXact Suture, 2-0 PTFE |
| 00854037007088 - eXact Suture 3-0 PTFE | 2024-04-10eXact Suture, 3-0 PTFE |
| 00854037007088 - eXact Suture 3-0 PTFE | 2024-04-10 eXact Suture, 3-0 PTFE |
| 00854037007101 - eXact Suture 4-0 PDO | 2024-04-10 eXact Suture, 4-0 PDO |
| 00854037007125 - eXact Suture 3-0 PDO | 2024-04-10 eXact Suture, 3-0 PDO |
| 00854037007149 - eXact 5.1 | 2023-03-08 |