Jaws insert, 5 x 330, assistant needle holder HICURA
EUDAMEDFDA UDIClass IIb (EU MDR)
Identity
- Trade Name
- Jaws insert, 5 x 330, assistant needle holder HICURA EUDAMEDOlympus FDA UDI
- Generic Name
- Suturing needle holder, reusable FDA UDI
- Device Name
- Hicura Accessories EUDAMEDJaws insert "HICURA", 5 x 330, assistant needle holder FDA UDI
- Model / Reference
- WA69384M EUDAMEDFDA UDI
- Description
- Jaws insert "HICURA", 5 x 330, assistant needle holder FDA UDI
Identifiers
- Catalog Number
- WA69384M FDA UDI
- Primary DI / UDI-DI
- 04042761079907 EUDAMEDFDA UDI
- Basic UDI-DI
- 4042761111004H EUDAMED
- Direct Marketing DI
- 04042761079907 EUDAMED
- 510(k) Number
- K140624 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- L1899 ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Suturing needle holder, 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Electrical-only medical device connection cable, reusable
Jaws insert, 5 x 330, assistant needle holder HICURA by Olympus Winter & Ibe GmbH — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4042761111004H | 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 4b9703b6-1065-4488-870c-8743151c88dd 61 fields · synced Oct 6, 2026
- FDA UDI 8aff3680-e058-4a33-bc59-13a7043ee7ec 36 fields · synced May 30, 2026
- EUDAMED d5b3ce84-aac7-4e61-a6a5-489b579d3a16 61 fields · synced Jul 14, 2026