FDA Registration
Active
🇺🇸 United States
Multipurpose Drainage Catheters and Sets
Reg #: 3005580113
·
FEI: 3005580113
·
Expires 2025
Products
3
Proprietary Names
4
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- COOK MEDICAL LLC
- Registration Number
- 3005580113
- FEI Number
- 3005580113
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 400 DANIELS WAY
- City
- Bloomington
- State
- IN
- ZIP
- 47404
- Country
- US
Regulatory Submissions
- 510(k) Number
- K173035
Owner / Operator
- Firm Name
- COOK MEDICAL
- Operator Number
- 9090900
- Address
- 400 DANIELS WAY, --
- City
- Bloomington
- State
- IN
- Postal Code
- 47404
- Country
- US
- Correspondent
- Ed - Sutkowski
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Nephrostomy, General & Plastic Surgery | GBO | Class 1 | General, Plastic Surgery | No | 2023-11-13 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2023-11-13 |
| Catheter, Nephrostomy | LJE | Class U | Unknown | No | 2023-11-13 |
Proprietary Names
Multipurpose Drainage Catheters and Sets
Pigtail Drainage Catheter Needle Set
Percutaneous Nephrostomy Set
Nephrostomy Pigtail Drainage Catheter
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)