FDA Registration
Active
🇺🇸 United States
Garware Fulflex USA Inc. (previously AVCOR Health Care Products, Inc.)
Reg #: 1649245
·
FEI: 3000214907
·
Expires 2026
Products
8
Proprietary Names
8
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- Garware Fulflex USA Inc. (previously AVCOR Health Care Products, Inc.)
- Registration Number
- 1649245
- FEI Number
- 3000214907
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 7879 Will Rogers Blvd
- City
- Fort Worth
- State
- TX
- ZIP
- 76140
- Country
- US
Owner / Operator
- Firm Name
- Garware Fulflex USA Inc.
- Operator Number
- 9029354
- Address
- 7879 Will Rogers Blvd, --
- City
- Fort Worth
- State
- TX
- Postal Code
- 76140
- Country
- US
- Correspondent
- Elisa - Maldonado-Holmertz
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 1997-02-04 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2014-01-13 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | Class 1 | General, Plastic Surgery | No | 2005-04-22 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2003-10-29 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2010-10-19 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2009-03-10 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2003-10-06 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2012-05-07 |
Proprietary Names
BANDAGE, ELASTIC
Pack, hot or cold, reusable
Splint, extremity, non-inflatable, external, non-sterile
BAG, ICE
Dressing, compression
FIBER, MEDICAL, ABSORBENT
Tourniquet, Nonpneumatic
Tape and bandage, adhesive
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device