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Fusion Extraction Balloon with Multiple Sizing
EUDAMEDFDA UDIClass I (EU MDR)
Ref FS-8.5-12-15-B
Identity
- Trade Name
- Fusion Extraction Balloon with Multiple Sizing EUDAMEDFusion FDA UDI
- Generic Name
- ERCP catheter, balloon, non-electrical, stone-retrieval FDA UDI
- Device Name
- Fusion Quattro Extraction Balloon EUDAMEDFusion Extraction Balloon with Multiple Sizing FDA UDI
- Model / Reference
- FS-8.5-12-15-B EUDAMEDG31538 FDA UDI
- Description
- Fusion Extraction Balloon with Multiple Sizing FDA UDI
Identifiers
- Catalog Number
- FS-8.5-12-15-B FDA UDI
- Primary DI / UDI-DI
- 00827002315389 EUDAMEDFDA UDI
- Basic UDI-DI
- 0827002WCM00000000047N2 EUDAMED
- 510(k) Number
- K040129 FDA UDI
- FDA Product Code
- GCA FDA UDI
- EMDN Code
- G03050101 DIGESTIVE ENDOSCOPY, RETRIEVAL BALLOON DEVICES EUDAMED
- GMDN Term
- ERCP catheter, balloon, non-electrical, stone-retrieval FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5010 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Fusion Extraction Balloon with Multiple Sizing by Wilson-Cook Medical, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0827002WCM00000000047N2 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Wilson-Cook Medical, Inc.
- EUDAMED SRN
- US-MF-000002658
- Authorised Representative
- COOK MEDICAL EUROPE LIMITED IE-AR-000000907
Sources (2)
- EUDAMED 7f689e8d-b74a-4e7d-bb70-33a1d347a425 61 fields · synced Jun 18, 2026
- FDA UDI c8605e7b-d69a-4f75-a515-a7b1ff73348c 37 fields · synced May 30, 2026