FDA Registration
Active
🇮🇪 Ireland
SurgiTrack
Reg #: 3011144486
·
FEI: 3011144486
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ArcRoyal uc
- Registration Number
- 3011144486
- FEI Number
- 3011144486
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Virginia Road
- City
- Kells Meath
- Country
- IE
Owner / Operator
- Firm Name
- O & M Halyard, Inc.
- Operator Number
- 10039033
- Address
- 1220 Old Alpharetta Rd. Ste 320
- City
- Alpharetta
- State
- GA
- Postal Code
- 30005
- Country
- US
- Correspondent
- Angela L Bunn
US Agent
- Business Name
- Owens & Distribution Inc.,
- Contact Name
- Angela Bunn
- Address
- 9120 Lockwood Blvd
- City
- Mechanicsville
- State
- VA
- ZIP
- 23116
- Country
- US
- [email protected]
- Phone
- 470 3647147
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| General Surgery Tray | LRO | Class 2 | General, Plastic Surgery | No | 2015-08-14 |
Proprietary Names
SurgiTrack
General Surgery Tray (Kit)
Knee Pack
Hip Pack
Hand Pack
Toe Nail Kit
General Purpose Kit
General Convenience Kit
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)