FDA Registration
Active
🇺🇸 United States
STERILIZATION WRAP
Reg #: 3014421917
·
FEI: 3014421917
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
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
Regulatory Submissions
- 510(k) Number
- K143053
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 |
|---|---|---|---|---|---|
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2018-05-02 |
Proprietary Names
STERILIZATION WRAP
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device