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Fusion Triple Lumen Needle Knife
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref FS-PRECUT
Identity
- Trade Name
- Fusion FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
- Device Name
- FUSION TRIPLE LUMEN NEEDLE KNIFE EUDAMEDFDA UDI
- Model / Reference
- FS-PRECUT EUDAMEDG31539 FDA UDI
- Description
- Fusion Triple Lumen Needle Knife FDA UDI
Identifiers
- Catalog Number
- FS-PRECUT FDA UDI
- Primary DI / UDI-DI
- 00827002315396 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00827002315396 EUDAMED
- 510(k) Number
- K040981 FDA UDI
- FDA Product Code
- KNS FDA UDI
- EMDN Code
- G03040202 PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN EUDAMED
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4300 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
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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 Triple Lumen Needle Knife by Wilson-Cook Medical, Inc. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00827002315396 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | 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 c13ce9b8-b3da-453e-a4c8-f213fe5bf664 61 fields · synced Jun 19, 2026
- FDA UDI a007c917-2acf-4fa0-8fa6-1c0118ffc9ea 37 fields · synced May 30, 2026