Identity
- Trade Name
- Huibregtse FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
- Device Name
- HUIBREGTSE NEEDLE KNIFE PAPILLOTOME EUDAMEDFDA UDI
- Model / Reference
- HPC-2 EUDAMEDG22037 FDA UDI
- Description
- Huibregtse Needle Knife Papillotome FDA UDI
Identifiers
- Catalog Number
- HPC-2 FDA UDI
- Primary DI / UDI-DI
- 00827002220379 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00827002220379 EUDAMED
- 510(k) Number
- K972674 FDA UDI
- FDA Product Code
- KNS FDA UDI
- EMDN Code
- G03040299 PAPILLOTOMES / SPHINCTEROTOMES - OTHER 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
Huibregtse Needle Knife Papillotome 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-00827002220379 | 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 3d3baca3-b629-420a-8f8d-7d49e9563af3 61 fields · synced Jul 18, 2026
- FDA UDI fb53022a-fa04-411d-b821-5e4787851d10 37 fields · synced May 29, 2026