Identity
- Trade Name
- EVOS FDA UDI
- Generic Name
- ERCP catheter, balloon, non-electrical, stone-retrieval FDA UDI
- Device Name
- REDUCTION FORCEPS FOR 3.5MM SCREW FDA UDI
- Model / Reference
- 71173306 FDA UDI
- Description
- REDUCTION FORCEPS FOR 3.5MM SCREW FDA UDI
Identifiers
- Catalog Number
- 71173306 FDA UDI
- Primary DI / UDI-DI
- 00885556781302 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- ERCP catheter, balloon, non-electrical, stone-retrieval FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: ERCP catheter, balloon, non-electrical, stone-retrieval
Evos by Smith & Nephew, Inc. — Class I — 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
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
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 941eaed7-013e-4b6d-aa23-1fda1867cfae 35 fields · synced Jun 8, 2026