| Primary Device ID | 03700512921080 |
| NIH Device Record Key | 78bbf681-aba7-4a8d-9c51-14e8d70832ad |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gynecology - 1 way Hysteroscopy set with aspiration tubing |
| Version Model Number | SOHY9102ST12 |
| Catalog Number | SOHY9102ST12 |
| 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 |
| Phone | +37797984232 |
| customer@rocamed.eu |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03700512901082 [Primary] |
| GS1 | 03700512911081 [Package] Contains: 03700512901082 Package: Box Label 1 [10 Units] In Commercial Distribution |
| GS1 | 03700512921080 [Package] Contains: 03700512911081 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 | 6 |
| Public Version Date | 2019-11-11 |
| Device Publish Date | 2016-10-11 |