FDA Registration
Active
🇺🇸 United States
MEDICAL SURGICAL SHOE
Reg #: 1122845
·
FEI: 1000123428
·
Expires 2025
Products
1
Proprietary Names
8
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 |
|---|---|---|---|---|---|
| Shoe, Cast | IPG | Class 1 | Physical Medicine | No | 2006-07-17 |
Proprietary Names
MEDICAL SURGICAL SHOE
Standard Open Toe Cast Boot
Body Armor Cast Shoe
Slimline Cast Boot
Low Profile Cast Shoe
Polycast Cast Boot
Canvas/Open Toe Cast Shoe
Vinyl Closed Toe Cast Boot
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device