| Primary Device ID | 03700512978008 |
| NIH Device Record Key | 3b9a5609-cd88-498e-b981-48f9dd658624 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OlyCath Curved 0 Eye 8 French |
| Version Model Number | ROTH8000ST245 |
| Catalog Number | OLCAC08 |
| Company DUNS | 401020409 |
| Company Name | Promepla |
| 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 | false |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | 03700512968009 [Primary] |
| GS1 | 03700512978008 [Package] Contains: 03700512968009 Package: Box 1 [10 Units] In Commercial Distribution |
| GS1 | 03700512988007 [Package] Package: Box 2 [6 Units] In Commercial Distribution |
| EYB | Catheter, Ureteral, Gastro-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 | 2020-05-14 |
| Device Publish Date | 2020-05-06 |