FDA Registration
Active
🇺🇸 United States
SHOULDER IMMOBILIZER
Reg #: 1122845
·
FEI: 1000123428
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
4
Classifications
1
Registration Details
- Registration Name
- DARCO INTERNATIONAL, INC.
- Registration Number
- 1122845
- FEI Number
- 1000123428
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 810 MEMORIAL BLVD.
- City
- HUNTINGTON
- State
- WV
- ZIP
- 25701
- Country
- US
Owner / Operator
- Firm Name
- DARCO INTERNATIONAL, INC.
- Operator Number
- 9001626
- Address
- 810 MEMORIAL BLVD., --
- City
- Huntington
- State
- WV
- Postal Code
- 25701
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2006-07-17 |
Proprietary Names
SHOULDER IMMOBILIZER
SLING AND SWATHE
DARCO ARM SLING
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device
Manufacture Medical Device