FDA Registration
Active
🇮🇸 Iceland
Tracheotomy attachments Stabiliser
Reg #: 3003764610
·
FEI: 3003764610
·
Expires 2025
Products
1
Proprietary Names
15
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 |
|---|---|---|---|---|---|
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 1993-01-01 |
Proprietary Names
Tracheotomy attachments Stabiliser
Philadelphia Tracheotomy Collar
Miami J
Foam Cervical Collar
Miami Jr
Miami J Select
NecLoc Kids
Philadelphia Adjustable Tracheotomy Collar
Papoose
Tracheotomy Attachments Halo
Patriot Collar
Miami JTO Thoracic Extension
NecLoc
Occian Back
Universal Cervical Collar
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility