Identity
- Trade Name
- Tri-Ex FDA UDI
- Generic Name
- ERCP catheter, balloon, non-electrical, stone-retrieval FDA UDI
- Device Name
- Tri-Ex Extraction Balloon FDA UDI
- Model / Reference
- G22533 FDA UDI
- Description
- Tri-Ex Extraction Balloon FDA UDI
Identifiers
- Catalog Number
- TX-12-B FDA UDI
- Primary DI / UDI-DI
- 00827002225336 FDA UDI
- 510(k) Number
- K953951 FDA UDI
- FDA Product Code
- GCA FDA UDI
- GMDN Term
- ERCP catheter, balloon, non-electrical, stone-retrieval FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5010 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
Yes
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
No
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, balloon, non-electrical, stone-retrieval
Tri-Ex by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as ERCP catheter, balloon, non-electrical, stone-retrieval.
- Retrieval Balloon short-wire compatible — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Anrei — Anrei Medical(HZ) Co., Ltd. · Class II
- Sterile Biliary Stone Retrieval Balloon Catheter — Micro-Tech (Nanjing) Co., Ltd. · Class II
- DURAGLIDE — Conmed Corporation · Class II
- Single Use Balloon Dilator V (with knife) — Olympus Medical Systems Corporation · Class II
- Retrieval Balloon short-wire compatible — Micro-Tech (Nanjing) Co., Ltd. · Class II
- DURAGLIDE — Conmed Corporation · Class II
- Single Use 3-Lumen Extraction Balloon V — Olympus Medical Systems Corporation · Class II
Cleared under the same submission
K953951 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Cook Incorporated
Sources (1)
- FDA UDI 74d5eb2a-b1a1-4220-a9c4-b209729c6f05 37 fields · synced Jun 8, 2026