| Primary Device ID | 00850033976106 |
| NIH Device Record Key | f4cbc77c-fba9-4da7-b1c1-6fe4b77ced96 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Symphion Controller - Refurbished |
| Version Model Number | FG-0612-R |
| Catalog Number | FG-0612-R |
| Company DUNS | 829616478 |
| Company Name | Minerva Surgical, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850033976106 [Primary] |
| GS1 | 08714729897279 [Previous] |
| PGT | Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-11 |
| Device Publish Date | 2022-05-03 |
| 00850033976250 - HERizon Medical Endoscope Image Processor | 2024-10-15 Medical Endoscope Image Processor For Use with HERizon Disposable Electronic Hysteroscope. |
| 10850033976264 - HERizon Disposable Electronic Hysteroscope | 2024-10-15 Disposable Electronic Hysteroscope For Use with HERizon Medical Endoscope Image Processor |
| 10850033976271 - HERizon Disposable Endoscopic Forceps - Biopsy | 2024-10-15 Disposable Endoscopic Forceps - Biopsy |
| 10850033976288 - HERizon Disposable Endoscopic Forceps - Foreign Body Grasper | 2024-10-15 Disposable Endoscopic Forceps - Foreign Body Grasper |
| 10850033976295 - HERizon Disposable Endoscopic Forceps – Alligator | 2024-10-15 Disposable Endoscopic Forceps – Alligator |
| 10850033976301 - HERizon Disposable Endoscopic Forceps - Inverted Tooth | 2024-10-15 Disposable Endoscopic Forceps - Inverted Tooth |
| 10850033976318 - HERizon Disposable Endoscopic Scissors | 2024-10-15 Disposable Endoscopic Scissors |
| 00850033976236 - INFINITY Fluid Management Accessory | 2024-08-20 Symphion Operative Hysteroscopy System, Fluid Management with filter for recirculation. For use with Symphion Controller. |