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Handle, size M, deactivatable ratchet HICURA
EUDAMEDFDA UDIClass I (EU MDR)
Ref WA69000M
Identity
- Trade Name
- Handle, size M, deactivatable ratchet HICURA EUDAMEDOlympus FDA UDI
- Generic Name
- Surgical instrument handle, non-torque-limiting FDA UDI
- Device Name
- Hicura Handle - ratchet EUDAMEDHandle "HICURA", size M, deactivatable ratchet FDA UDI
- Model / Reference
- WA69000M EUDAMEDFDA UDI
- Description
- Handle "HICURA", size M, deactivatable ratchet FDA UDI
Identifiers
- Catalog Number
- WA69000M FDA UDI
- Primary DI / UDI-DI
- 04042761078276 EUDAMEDFDA UDI
- Basic UDI-DI
- 40427611106252 EUDAMED
- Direct Marketing DI
- 04042761078276 EUDAMED
- 510(k) Number
- K140624 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- L1299 LAPAROSCOPIC AND THORACOSCOPIC INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical instrument handle, non-torque-limiting FDA UDI
Classification
- Device Class
- Class I 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
Yes
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
Handle, size M, deactivatable ratchet HICURA by Olympus Winter & Ibe GmbH — Class I — 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 | 40427611106252 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Olympus Winter & Ibe GmbH
- EUDAMED SRN
- DE-MF-000006729
Sources (3)
- EUDAMED 79d17d76-1455-47d5-9c95-370e959d7884 61 fields · synced Jul 31, 2026
- FDA UDI 9d9ffe72-9f66-45a2-8be7-e63a0a9d896a 36 fields · synced May 30, 2026
- EUDAMED 31566a66-d9a7-449a-91fb-d20b60bb3439 61 fields · synced Jul 31, 2026