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
- G25166 FDA UDI
- Description
- Tri-Ex Extraction Balloon FDA UDI
Identifiers
- Catalog Number
- TXR-12-A FDA UDI
- Primary DI / UDI-DI
- 00827002251663 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
- Not 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
Tri-Ex by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 531f108e-fda8-4296-aa02-4212a3af2027 38 fields · synced Jun 8, 2026