FDA Registration
Active
🇮🇸 Iceland
Premium Contact Closure Arm Sling
Reg #: 3003764610
·
FEI: 3003764610
·
Expires 2025
Products
1
Proprietary Names
17
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- OSSUR H/F
- Registration Number
- 3003764610
- FEI Number
- 3003764610
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- GRJOTHALS 1-5
- City
- REYKJAVIK
- Country
- IS
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
US Agent
- Business Name
- Ossur
- Contact Name
- Katla Axelsdottir
- Address
- 200 Spectrum Center Drive, Suite 700
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
- [email protected]
- Phone
- 949 3823833
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 1991-02-12 |
Proprietary Names
Premium Contact Closure Arm Sling
Shoulder Abduction Sling
Formfit Shoulder Brace
Formfit Shoulder Brace with Abduction
Formfit Shoulder Brace with External Rotation
Formfit Shoulder Brace with Airplane
Padded Strap Shoulder Immobilizer
High Arm Sling
Axilla Pillow
External Rotation Pillow
Premium Shoulder Immobiliser
Pediatric Universal Arm Sling
Premium Padded Arm Sling
Buckle Closure Arm Sling
Bergschultz Universal Arm Sling
Sling & Swathe
Premium Shoulder Immobilizer
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility