Identity
- Trade Name
- Cook FDA UDI
- Generic Name
- ERCP catheter, non-balloon, non-electrical, single-use FDA UDI
- Device Name
- Cook Endoscopic Cholangiography Set FDA UDI
- Model / Reference
- G09331 FDA UDI
- Description
- Cook Endoscopic Cholangiography Set FDA UDI
Identifiers
- Catalog Number
- C-OECS-500-MIXTER FDA UDI
- Primary DI / UDI-DI
- 00827002093317 FDA UDI
- FDA Product Code
- GBZ FDA UDI
- GMDN Term
- ERCP catheter, non-balloon, non-electrical, single-use 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: ERCP catheter, non-balloon, non-electrical, single-use
Cook by Cook Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as ERCP catheter, non-balloon, non-electrical, single-use.
- Reddick Cholangiogram Catheter — LeMaitre Vascular, Inc. · Class I
- EXAMINE — Conmed Corporation · Class II
- Single Use Cannula V — Olympus Medical Systems Corporation · Class II
- Single Use 2-Lumen Cannula V — Olympus Medical Systems Corporation · Class II
- Single Use Cannula V — Olympus Medical Systems Corporation · Class II
- Symmetry Surgical — Olsen Medical · Class I
- Contour ERCP Cannula — Boston Scientific · Class II
- Reddick Scoop Tip Cholangiogram Catheter — LeMaitre Vascular, Inc. · 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 4b562967-15a3-41f3-925f-0b20fc35aaa5 36 fields · synced Jun 8, 2026