FDA Registration
Active
🇺🇸 United States
STETRIX INC.
Reg #: 3005550381
·
FEI: 3005550381
·
Expires 2026
Products
4
Proprietary Names
2
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- STETRIX INC.
- Registration Number
- 3005550381
- FEI Number
- 3005550381
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6935 Appling Farms Pkwy Ste 103
- City
- Memphis
- State
- TN
- ZIP
- 38133
- Country
- US
Regulatory Submissions
- 510(k) Number
- DEN160005
Owner / Operator
- Firm Name
- Stetrix Inc.
- Operator Number
- 9078700
- Address
- 7531 Bartlett Corporate Cv E, Suite 103
- City
- Bartlett
- State
- TN
- Postal Code
- 38133
- Country
- US
- Correspondent
- David D Blurton
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Pressure Applying | KNM | Class 1 | Physical Medicine | No | 2005-10-18 |
| Hemorrhoid Prevention Pressure Wedge | OOA | Class 2 | Obstetrics/Gynecology | No | 2013-08-19 |
| Tape, Orthopedic | HXT | Class 1 | General, Plastic Surgery | No | 2009-09-14 |
| Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery | PNU | Class 2 | Obstetrics/Gynecology | No | 2022-12-21 |
Proprietary Names
Hem-Avert, Labor Guard
Tissue Retention System (TRS), Pannus Retention System (PRS), Panni, Panni-XL, Jannus
Establishment Types
Manufacture Medical Device