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Jaws insert, 5 x 430, hook scissors, monopolar HICURA
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref WA69376L
Identity
- Trade Name
- Jaws insert, 5 x 430, hook scissors, monopolar HICURA EUDAMEDOlympus FDA UDI
- Generic Name
- Rigid endoscopic scissors, reusable FDA UDI
- Device Name
- Hicura Scissors - monopolar EUDAMEDJaws insert "HICURA", 5 x 430, hook scissors, monopolar FDA UDI
- Model / Reference
- WA69376L EUDAMEDFDA UDI
- Description
- Jaws insert "HICURA", 5 x 430, hook scissors, monopolar FDA UDI
Identifiers
- Catalog Number
- WA69376L FDA UDI
- Primary DI / UDI-DI
- 04042761079846 EUDAMEDFDA UDI
- Basic UDI-DI
- 40427611106354 EUDAMED
- Direct Marketing DI
- 04042761079846 EUDAMED
- 510(k) Number
- K140624 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- L180202 ENDOSCOPIC ELECTROSURGERY SCISSORS, REUSABLE EUDAMED
- GMDN Term
- Rigid endoscopic scissors, 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
Jaws insert, 5 x 430, hook scissors, monopolar HICURA by Olympus Winter & Ibe GmbH — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 40427611106354 | 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 20cb9af8-49a3-42fd-9002-2ec3840f1471 61 fields · synced Jun 18, 2026
- FDA UDI 2a2c000e-0caf-440b-9a2a-e21616926439 36 fields · synced May 30, 2026
- EUDAMED 22835e78-7166-475d-a08f-bcc9a73fa036 61 fields · synced Jun 18, 2026