Identity
- Trade Name
- Shaft, 5 x 330, bipolar HICURA EUDAMEDOlympus FDA UDI
- Generic Name
- Orthopaedic implantation sleeve, reusable FDA UDI
- Device Name
- Hicura Shaft - bipolar EUDAMEDShaft "HICURA", 5 x 330, bipolar FDA UDI
- Model / Reference
- WA69400M EUDAMEDFDA UDI
- Description
- Shaft "HICURA", 5 x 330, bipolar FDA UDI
Identifiers
- Catalog Number
- WA69400M FDA UDI
- Primary DI / UDI-DI
- 04042761079969 EUDAMEDFDA UDI
- Basic UDI-DI
- 40427611106456 EUDAMED
- Direct Marketing DI
- 04042761079969 EUDAMED
- 510(k) Number
- K140624 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- L180302 ENDOSCOPIC ELECTROSURGERY HANDPIECES, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic implantation sleeve, reusable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Shaft, 5 x 330, bipolar HICURA by Olympus Winter & Ibe GmbH — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 40427611106456 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Olympus Winter & Ibe GmbH
- EUDAMED SRN
- DE-MF-000006729
Sources (3)
- EUDAMED 2f9e71ce-7e92-4c03-9f17-813e73675b67 61 fields · synced Jun 18, 2026
- FDA UDI 3bca303e-51c5-487b-8362-aa9f545304b4 36 fields · synced May 30, 2026
- EUDAMED f0d9d97e-aa78-49be-b2ad-141f667e0528 61 fields · synced Jun 11, 2026