Identity
- Trade Name
- Cook FDA UDI
- Generic Name
- Biliary/vascular irrigation catheter FDA UDI
- Device Name
- Irrigation Catheter FDA UDI
- Model / Reference
- G53746 FDA UDI
- Description
- Irrigation Catheter FDA UDI
Identifiers
- Catalog Number
- PU5.0-35-6-W-NS-0-IG FDA UDI
- Primary DI / UDI-DI
- 00827002537460 FDA UDI
- FDA Product Code
- GBX FDA UDI
- GMDN Term
- Biliary/vascular irrigation catheter FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Biliary/vascular irrigation catheter
Cook by Cook Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Biliary/vascular irrigation catheter.
- FOGARTY — Edwards Lifesciences LLC · Class I
- FOGARTY — Edwards Lifesciences LLC · Class I
- FOGARTY — Edwards Lifesciences LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cook Incorporated
Sources (1)
- FDA UDI cdee3e64-8121-4e71-862f-1544300aa0e5 36 fields · synced Jun 8, 2026