FDA Registration
Active
🇺🇸 United States
Formfit Wrist and Forearm Universal
Reg #: 2242474
·
FEI: 2242474
·
Expires 2025
Products
1
Proprietary Names
17
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- OSSUR AMERICAS
- Registration Number
- 2242474
- FEI Number
- 2242474
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 680 Grove Rd
- City
- West Deptford
- State
- NJ
- ZIP
- 08086
- Country
- US
Owner / Operator
- Firm Name
- OSSUR Americas
- Operator Number
- 9026971
- Address
- 200 Spectrum Center Drive, Suite 700
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 1991-02-11 |
Proprietary Names
Formfit Wrist and Forearm Universal
Formfit Wrist
Formfit Wrist & Forearm
Formfit Pediatric Thumb Spica
Formfit Pediatric Wrist Universal
Formfit Thumb OA Day
Formfit Thumb OA Night
Wrist Brace
Formfit Pro Wrist
Formfit Universal Wrist
Spectra Wrist Brace
Exoform Wrist
Universal Thumb Splint
Formfit Thumb
Formfit Universal Thumb
Exoform Carpal Tunnel Wrist
Thumb Spica
Establishment Types
Repack or Relabel Medical Device