| Primary Device ID | 07290019174448 |
| NIH Device Record Key | a68cf259-0b01-4166-a1e1-8a8a63e12267 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mendit Single Applicator Set |
| Version Model Number | Mendit Single Applicator Set -- permanent suture ( |
| Catalog Number | ES0654 |
| Company DUNS | 600469711 |
| Company Name | ESCALA MEDICAL LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 * keep dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 * keep dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 * keep dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 * keep dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 * keep dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 * keep dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 * keep dry |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290019174448 [Primary] |
| PBQ | Fixation, Non-Absorbable Or Absorbable, For Pelvic Use |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-18 |
| Device Publish Date | 2026-03-10 |
| 07290019174448 | The Mendit is a single-use repair system which enables anchoring of sutures to ligaments of the |
| 07290019174431 | The Mendit is a single-use repair system which enables anchoring of sutures to ligaments of the |
| 07290019174240 | The Mendit is a single-use repair system which enables anchoring of sutures to ligaments of the |
| 07290019174233 | The Mendit is a single-use repair system which enables anchoring of sutures to ligaments of the |
| 07290019174226 | The Mendit is a single-use repair system which enables anchoring of sutures to ligaments of the |
| 07290019174219 | The Mendit is a single-use repair system which enables anchoring of sutures to ligaments of the |