FDA Registration
Active
🇺🇸 United States
Uterine Manipulator
Reg #: 3032109
·
FEI: 3001238683
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Gynex Corporation
- Registration Number
- 3032109
- FEI Number
- 3001238683
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 6631 Browning Dr
- City
- North Richland Hills
- State
- TX
- ZIP
- 76180
- Country
- US
Regulatory Submissions
- 510(k) Number
- K022503
Owner / Operator
- Firm Name
- GYNEX CORP.
- Operator Number
- 9031621
- Address
- 6631 Browning Dr, --
- City
- North Richland Hills
- State
- TX
- Postal Code
- 76180
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cannula, Manipulator/Injector, Uterine | LKF | Class 2 | Obstetrics/Gynecology | No | 2007-11-07 |
Proprietary Names
Uterine Manipulator
Establishment Types
Repack or Relabel Medical Device