| Primary Device ID | 03700512978596 |
| NIH Device Record Key | 5acda16e-e106-4245-ac75-624a2385e8a8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | X-Filter basket |
| Version Model Number | ROXE363609ST |
| Catalog Number | XF36150 |
| Company DUNS | 401020409 |
| Company Name | Promepla |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03700512968597 [Primary] |
| GS1 | 03700512978596 [Package] Contains: 03700512968597 Package: Box [1 Units] In Commercial Distribution |
| GS1 | 03700512988595 [Package] Package: Box [4 Units] In Commercial Distribution |
| OCY | Endoscopic Guidewire, Gastroenterology-Urology |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-06 |
| Device Publish Date | 2022-04-28 |