FDA Registration
Active
🇺🇸 United States
OPERATING ROOM SHOE COVER
Reg #: 3014421917
·
FEI: 3014421917
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
4
Classifications
1
Registration Details
- Registration Name
- O&M Halyard, Inc.
- Registration Number
- 3014421917
- FEI Number
- 3014421917
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1220 Old Alpharetta Rd Ste 320
- City
- Alpharetta
- State
- GA
- ZIP
- 30005
- Country
- US
Owner / Operator
- Firm Name
- O&M Halyard, Inc.
- Operator Number
- 10057479
- Address
- 1220 Old Alpharetta Rd, Suite 320
- City
- Alpharetta
- State
- GA
- Postal Code
- 30005
- Country
- US
- Correspondent
- Angela Bunn
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2018-05-02 |
Proprietary Names
OPERATING ROOM SHOE COVER
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198