| Primary Device ID | 05425029282599 |
| NIH Device Record Key | 0ffc2ec7-cd7d-4e5d-896e-1ea304b6d507 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | endomina EZFuse system |
| Version Model Number | endomina EZFuse system |
| Company DUNS | 400000750 |
| Company Name | Endo Tools Therapeutics |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05425029282087 [Primary] |
| GS1 | 05425029282599 [Package] Contains: 05425029282087 Package: Pallet [24 Units] In Commercial Distribution |
| OCW | Endoscopic Tissue Approximation Device |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-27 |
| Device Publish Date | 2026-03-19 |
| 05425029282643 - endomina EZFuse suture | 2026-03-27 endomina EZFuse suture |
| 05425029282599 - endomina EZFuse system | 2026-03-27endomina EZFuse system composed of 1 endomina platform and 6 endomina EZFuse suture |
| 05425029282599 - endomina EZFuse system | 2026-03-27 endomina EZFuse system composed of 1 endomina platform and 6 endomina EZFuse suture |
| 05425029282117 - endomina platform | 2022-07-27 endomina platform primary packaging (x1) |
| 05425029282070 - endomina system | 2022-07-27 endomina system is composed of 1 endomina platform and 6 TAPES |
| 05425029282698 - TAPES | 2022-07-27 TAPES primary packaging (x1) |