Identity
- Trade Name
- Surgimedics® FDA UDI
- Generic Name
- ERCP catheter, non-balloon, non-electrical, single-use FDA UDI
- Device Name
- Cholangiography Catheter FDA UDI
- Model / Reference
- 908010-000 FDA UDI
- Description
- Cholangiography Catheter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814716020005 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: ERCP catheter, non-balloon, non-electrical, single-use
Surgimedics® by Coastal Life Technologies, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as ERCP catheter, non-balloon, non-electrical, single-use.
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- Olsen — COOK INCORPORATED · Class I
- Single Use Cannula V — Olympus Medical Systems Corporation · Class II
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
- Coastal Life Technologies, Inc.
Sources (1)
- FDA UDI cca559e6-ba3e-487b-8650-8d65579b09be 33 fields · synced May 31, 2026