| Primary Device ID | 00850033976137 |
| NIH Device Record Key | 5d3d678d-73b3-4548-92c7-a3dc9b1626c1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Symphion 6.3 Hysteroscope - Refurbished |
| Version Model Number | FG-0703-R |
| Catalog Number | FG-0703-R |
| Company DUNS | 829616478 |
| Company Name | Minerva Surgical, Inc. |
| 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 | 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 Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850033976137 [Primary] |
| GS1 | 08714729905806 [Previous] |
| HIH | Hysteroscope (And Accessories) |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850033976137]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00850033976137]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00850033976137]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00850033976137]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00850033976137]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00850033976137]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00850033976137]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00850033976137]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00850033976137]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00850033976137]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00850033976137]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00850033976137]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00850033976137]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00850033976137]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00850033976137]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00850033976137]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00850033976137]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00850033976137]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00850033976137]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00850033976137]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00850033976137]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00850033976137]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00850033976137]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00850033976137]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00850033976137]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00850033976137]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00850033976137]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00850033976137]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00850033976137]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00850033976137]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00850033976137]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-11 |
| Device Publish Date | 2022-05-03 |
| 00850033976236 - INFINITY Fluid Management Accessory | 2024-08-20 Symphion Operative Hysteroscopy System, Fluid Management with filter for recirculation. For use with Symphion Controller. |
| 00850033976243 - Symphion Fluid Deficit Readout | 2024-08-20 Symphion Operative Hysteroscopy System Fluid Deficit Readout For use with Symphion Controller SW Version 3.0.0 or higher. Conten |
| 00850033976168 - Genesys HTA Scope Adapter, STORZ | 2022-10-27 STORZ Scope Adapter, for use only with Genesys HTA System |
| 00850033976175 - Genesys HTA Scope Adapter, WOLF | 2022-10-27 WOLF Scope Adapter, for use only with Genesys HTA System |
| 00850033976182 - Genesys HTA Scope Adapter, ACMI | 2022-10-27 ACMI Scope Adapter, for use only with Genesys HTA System |
| 00850033976199 - Genesys HTA Scope Adapter, OLYMPUS | 2022-10-27 OLYMPUS Scope Adapter, for use only with Genesys HTA System |
| 00850033976014 - Genesys HTA Control Unit | 2022-06-16 Genesys HTA 115V Control Unit |
| 00850033976021 - Genesys HTA Control Unit - Refurbished | 2022-06-16 Genesys HTA 115V Control Unit (Refurbished) |