| Primary Device ID | 03700512922001 |
| NIH Device Record Key | cd484b3a-b659-4523-8649-a1e10215837b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Urology TURP Gravity Tubing |
| Version Model Number | GB1TURP |
| Catalog Number | ONGR2000ST12 |
| 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 | 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 | 03700512902003 [Primary] |
| GS1 | 03700512912002 [Package] Contains: 03700512902003 Package: Box Label 1 [10 Units] In Commercial Distribution |
| GS1 | 03700512922001 [Package] Contains: 03700512912002 Package: Box Label 2 [4 Units] In Commercial Distribution |
| GBX | Catheter, Irrigation |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-02-11 |
| Device Publish Date | 2019-10-18 |