FDA Registration
Active
🇺🇸 United States
FABRITEQ
Reg #: 3010824458
·
FEI: 3010824458
·
Expires 2026
Products
11
Proprietary Names
1
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- FABRITEQ
- Registration Number
- 3010824458
- FEI Number
- 3010824458
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 11220 Gilbert Dr
- City
- Knoxville
- State
- TN
- ZIP
- 37932
- Country
- US
Owner / Operator
- Firm Name
- FabriTEQ
- Operator Number
- 10046621
- Address
- 11220 Gilbert Dr
- City
- Knoxville
- State
- TN
- Postal Code
- 37932
- Country
- US
- Correspondent
- David E Dewitt
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wound Dressing With Animal-Derived Material(S) | KGN | Class U | Unknown | No | 2025-09-10 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2016-02-25 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2016-04-21 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2019-12-19 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2016-02-25 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2017-01-11 |
| Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery | PNU | Class 2 | Obstetrics/Gynecology | No | 2023-05-22 |
| Administration Set Securement Device | PUK | Class 1 | General Hospital | No | 2017-06-26 |
| Holder, Ureteral Catheter | EYJ | Class 1 | Gastroenterology, Urology | No | 2014-04-16 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2014-04-16 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2015-04-24 |
Proprietary Names
SpO2 Sensor Wrap
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)