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Jaws insert, 5 x 430, severing, monopolar HICURA
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref WA69392L
Identity
- Trade Name
- Jaws insert, 5 x 430, severing, monopolar HICURA EUDAMEDOlympus FDA UDI
- Generic Name
- Rigid endoscopic biopsy forceps, reusable FDA UDI
- Device Name
- Hicura Forceps - monopolar EUDAMEDJaws insert "HICURA", 5 x 430, severing, monopolar FDA UDI
- Model / Reference
- WA69392L EUDAMEDFDA UDI
- Description
- Jaws insert "HICURA", 5 x 430, severing, monopolar FDA UDI
Identifiers
- Catalog Number
- WA69392L FDA UDI
- Primary DI / UDI-DI
- 04042761079945 EUDAMEDFDA UDI
- Basic UDI-DI
- 4042761110595D EUDAMED
- Direct Marketing DI
- 04042761079945 EUDAMED
- 510(k) Number
- K140624 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- L180402 ENDOSCOPIC ELECTROSURGERY FORCEPS, REUSABLE EUDAMED
- GMDN Term
- Rigid endoscopic biopsy forceps, 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, severing, 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 | 4042761110595D | 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 fdf96601-47b3-429f-9d6b-98a3f3e32c17 61 fields · synced Jul 9, 2026
- FDA UDI e5d5ecd3-542b-423c-a301-ac2cb8ff44e0 36 fields · synced May 30, 2026
- EUDAMED e65db7e7-ed9a-4688-b53e-5f84ba2bbae6 61 fields · synced Jul 9, 2026