| Primary Device ID | 03700512978220 |
| NIH Device Record Key | 54fde0b1-4c5c-4ced-9054-4d8529774766 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tuohy Borst Simple |
| Version Model Number | ROMTB-ST245 |
| Catalog Number | RTBS |
| 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 | false |
| Manufacturing Date | true |
| 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 | 03700512968221 [Primary] |
| GS1 | 03700512978220 [Package] Contains: 03700512968221 Package: Box 1 [10 Units] In Commercial Distribution |
| GS1 | 03700512988229 [Package] Package: Box 2 [16 Units] In Commercial Distribution |
| GBX | Catheter, Irrigation |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-04 |
| Device Publish Date | 2021-02-24 |