| Primary Device ID | 08436568350882 |
| NIH Device Record Key | f404cd49-cd7a-4577-9bf6-ae29ee5217b5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Remeex System -Readjustment kit Long |
| Version Model Number | AR-01L |
| Company DUNS | 513271056 |
| Company Name | DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL |
| 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 | true |
| Manufacturing Date | false |
| 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 | 08436568350882 [Primary] |
| OTM | Mesh, Surgical, For Stress Urinary Incontinence, Male |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-27 |
| Device Publish Date | 2020-10-19 |
| 08436568350141 - Anchorsure | 2020-10-27 |
| 08436568350882 - Remeex System -Readjustment kit Long | 2020-10-27 |
| 08436568350882 - Remeex System -Readjustment kit Long | 2020-10-27 |
| 08436568350899 - Male Remeex System - Thread Passer | 2020-10-27 |
| 08437007606027 - Remeex System (for Female Urinary Incontinence) | 2020-10-27 |
| 08437007606034 - Male Remeex System | 2020-10-27 |
| 08437007606058 - Needleless Sling | 2020-10-27 |
| 08437007606065 - KIM (Knotless Incontinence Mesh) | 2020-10-27 |
| 08437007606072 - Remeex System -Readjustment kit | 2020-10-27 |