| Primary Device ID | 03700512922056 |
| NIH Device Record Key | 103592be-5a69-4723-becd-d24daa30ea10 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Urology TURP 2 Spike |
| Version Model Number | RF2TURP |
| Catalog Number | SOUR9201ST12 |
| 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 | 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 | 03700512902058 [Primary] |
| GS1 | 03700512912057 [Package] Contains: 03700512902058 Package: Box Label 1 [10 Units] In Commercial Distribution |
| GS1 | 03700512922056 [Package] Contains: 03700512912057 Package: Box Label 2 [4 Units] In Commercial Distribution |
| FHF | System, Evacuator, Fluid |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-02-11 |
| Device Publish Date | 2019-10-21 |