| Primary Device ID | 00860014822711 |
| NIH Device Record Key | 610fd8d4-d590-421b-838c-3aaaf7fb18f7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Secure Suture Locking Device |
| Version Model Number | D5000000 |
| Company DUNS | 145126274 |
| Company Name | Endofix Medical Technologies, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 | 00860014822711 [Primary] |
| FGE | Stents, Drains And Dilators For The Biliary Ducts |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-10 |
| Device Publish Date | 2026-02-02 |
| 00860014822704 - EndoFix Tissue Fixation Device | 2026-02-10 EndoFix Tissue Fixation Device-Enables the approximation of soft tissue in the gastrointestinal (GI) tract using a suture-based |
| 00860014822711 - Secure Suture Locking Device | 2026-02-10Secure Suture Locking Device – Secures the implant assembly with an implant grade suture lock and cuts the suture once approximation is complete. |
| 00860014822711 - Secure Suture Locking Device | 2026-02-10 Secure Suture Locking Device – Secures the implant assembly with an implant grade suture lock and cuts the suture once approx |