Identity
- Trade Name
- Fusion FDA UDI
- Generic Name
- Endoscopic guidewire holder FDA UDI
- Device Name
- FUSION WIRE GUIDE LOCKING DEVICE EUDAMEDFDA UDI
- Model / Reference
- FS-WL-O-S EUDAMEDG31522 FDA UDI
- Description
- Fusion Wire Guide Locking Device FDA UDI
Identifiers
- Catalog Number
- FS-WL-O-S FDA UDI
- Primary DI / UDI-DI
- 00827002315228 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00827002315228 EUDAMED
- FDA Product Code
- OCY FDA UDI
- EMDN Code
- G0380 DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Endoscopic guidewire holder FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Gastro-urological guidewire, single-use
Fusion Wire Guide Locking Device by Wilson-Cook Medical, Inc. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastro-urological guidewire, single-use.
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Manufacturer's product page: Acrobat® 2 Calibrated Tip Wire Guide
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00827002315228 | 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 16532b70-9452-4c43-be46-48f9f30d746a 61 fields · synced Jun 18, 2026
- FDA UDI c3bb3465-8521-44da-8894-088eab5c0a4d 36 fields · synced May 30, 2026