FDA Registration
Active
🇺🇸 United States
Vinyl Splint
Reg #: 3010694026
·
FEI: 3010694026
·
Expires 2025
Products
1
Proprietary Names
22
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BREG, INC.
- Registration Number
- 3010694026
- FEI Number
- 3010694026
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2835 Fortune Cir W
- City
- Indianapolis
- State
- IN
- ZIP
- 46241
- Country
- US
Owner / Operator
- Firm Name
- Breg Inc
- Operator Number
- 10041297
- Address
- 2382 Faraday Avenue, Suite 300
- City
- Carlsbad
- State
- CA
- Postal Code
- 92008
- Country
- US
- Correspondent
- Monique Zamora
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2012-08-17 |
Proprietary Names
Vinyl Splint
Elasto-Fit Wrist Support
Wrist Guard
Thumb Support
Classic Wrist Brace
Versafit Wrist Brace
Universal Wrist Brace
Universal Wrist Splint
Versafit Thumb
Wrist Stabilizer Cock-Up
Apollo Wrist Brace
Low Profile Wrist
Wrist Cock Up Splint
Contender Brace
Wrist Mate
Thumbster
Wrist Pro
Wrist Lacer
Premier Thumb Splint
Thumb Guard
Wrist Complete
Universal Thumb Lacer
Establishment Types
Repack or Relabel Medical Device