Identity
- Trade Name
- Anrei FDA UDI
- Generic Name
- ERCP catheter, balloon, non-electrical, stone-retrieval FDA UDI
- Device Name
- Stone Retrieval Balloon Catheter FDA UDI
- Model / Reference
- RBQD-23200-12-15-18 FDA UDI
- Description
- Stone Retrieval Balloon Catheter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06948318963119 FDA UDI
- 510(k) Number
- K210660 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: ERCP catheter, balloon, non-electrical, stone-retrieval
Anrei by Anrei Medical(HZ) Co., Ltd. — 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
- 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
- Retrieval Balloon short-wire compatible — Micro-Tech (Nanjing) Co., Ltd. · Class II
Cleared under the same submission
K210660 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
- Anrei Medical(HZ) Co., Ltd.
Sources (1)
- FDA UDI 623ed235-0029-44d0-b410-25a285ea5411 34 fields · synced Jun 8, 2026