FDA Registration
Active
🇺🇸 United States
Sof-Flex, Double Pigtail Ureteral Stent Set Wire Guide with Hydrophilic Coating
Reg #: 1820334
·
FEI: 1820334
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Cook Incorporated
- Registration Number
- 1820334
- FEI Number
- 1820334
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 750 DANIELS WAY
- City
- Bloomington
- State
- IN
- ZIP
- 47404
- Country
- US
Owner / Operator
- Firm Name
- COOK, INC.
- Operator Number
- 1820334
- Address
- 750 DANIELS WAY
- City
- Bloomington
- State
- IN
- Postal Code
- 47404
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stent, Ureteral | FAD | Class 2 | Gastroenterology, Urology | No | 2023-10-18 |
Proprietary Names
Sof-Flex, Double Pigtail Ureteral Stent Set Wire Guide with Hydrophilic Coating
Black Silicone Filiform Double Pigtail Ureteral Stent Set Wire Guide With Hydrophilic Coating
Black Silicone Filiform Dbl Pigtail Ureteral Stent Set Wire Guide With Hydrophilic Coating
Establishment Types
Manufacture Device in the United States for Export Only