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Jaws insert, 5 x 330, Precision, monopolar HICURA
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref WA69322MRef WA69354M
Identity
- Trade Name
- Jaws insert, 5 x 330, Precision, monopolar HICURA EUDAMEDOlympus FDA UDI
- Generic Name
- Dissection forceps FDA UDIRigid endoscopic tissue manipulation forceps, reusable FDA UDI
- Device Name
- Hicura Forceps - monopolar EUDAMEDJaws insert "HICURA", 5 x 330, Precision, monopolar FDA UDI
- Model / Reference
- WA69322M EUDAMEDFDA UDIWA69354M EUDAMEDFDA UDI
- Description
- Jaws insert "HICURA", 5 x 330, Precision, monopolar FDA UDI
Identifiers
- Catalog Number
- WA69354M FDA UDIWA69322M FDA UDI
- Primary DI / UDI-DI
- 04042761079310 EUDAMEDFDA UDI04042761079686 EUDAMEDFDA UDI
- Basic UDI-DI
- 4042761110595D EUDAMED
- Direct Marketing DI
- 04042761079310 EUDAMED04042761079686 EUDAMED
- 510(k) Number
- K140624 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- L180402 ENDOSCOPIC ELECTROSURGERY FORCEPS, REUSABLE EUDAMED
- GMDN Term
- Dissection forceps FDA UDIRigid 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Jaws insert, 5 x 330, Precision, 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 (6)
- EUDAMED 7a4bb382-4288-4e4b-883c-a70b13db7dd3 61 fields · synced Jul 9, 2026
- EUDAMED 65c227f5-a250-4ed4-8483-854f1249ce7b 61 fields · synced May 18, 2026
- FDA UDI 00fba6c6-0c2d-47fd-96fb-33f185288916 34 fields · synced May 30, 2026
- FDA UDI ea59ee83-b415-4e9f-9989-69b991339fed 36 fields · synced May 30, 2026
- EUDAMED 2b1e0acd-820d-4996-b010-a8f8891f9c4e 61 fields · synced Jul 9, 2026
- EUDAMED 6d40804f-a330-4ab4-ba74-33beaf1ee464 61 fields · synced Jul 9, 2026