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Jaws insert, 5 x 330, Tear drop, monopolar HICURA
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref WA69362M
Identity
- Trade Name
- Jaws insert, 5 x 330, Tear drop, monopolar HICURA EUDAMEDOlympus FDA UDI
- Generic Name
- Rigid endoscopic tissue manipulation forceps, reusable FDA UDI
- Device Name
- Hicura Forceps - monopolar EUDAMEDJaws insert "HICURA", 5 x 330, Tear drop, monopolar FDA UDI
- Model / Reference
- WA69362M EUDAMEDFDA UDI
- Description
- Jaws insert "HICURA", 5 x 330, Tear drop, monopolar FDA UDI
Identifiers
- Catalog Number
- WA69362M FDA UDI
- Primary DI / UDI-DI
- 04042761083645 EUDAMEDFDA UDI
- Basic UDI-DI
- 4042761110595D EUDAMED
- Direct Marketing DI
- 04042761083645 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 tissue manipulation 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Jaws insert, 5 x 330, Tear drop, 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 0666baba-c667-4006-aad5-c896a70ee79c 61 fields · synced Jul 10, 2026
- FDA UDI dc158df2-3097-42ff-89a8-8e7180cc0da8 36 fields · synced May 30, 2026
- EUDAMED 3e6ab95f-6eec-4a35-be41-63d2da751392 61 fields · synced Jul 10, 2026