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Jaws insert, 5 x 250, assistant needle holder HICURA
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref WA69384S
Identity
- Trade Name
- Jaws insert, 5 x 250, assistant needle holder HICURA EUDAMEDOlympus FDA UDI
- Generic Name
- Suturing needle holder, reusable FDA UDI
- Device Name
- Hicura Accessories EUDAMEDJaws insert "HICURA", 5 x 250, assistant needle holder FDA UDI
- Model / Reference
- WA69384S EUDAMEDFDA UDI
- Description
- Jaws insert "HICURA", 5 x 250, assistant needle holder FDA UDI
Identifiers
- Catalog Number
- WA69384S FDA UDI
- Primary DI / UDI-DI
- 04042761079914 EUDAMEDFDA UDI
- Basic UDI-DI
- 4042761111004H EUDAMED
- Direct Marketing DI
- 04042761079914 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
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 250, assistant needle holder 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 | 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 0c61f67c-85e0-4788-bd86-4274676e9adc 61 fields · synced Jun 19, 2026
- FDA UDI 95df57f6-9506-4b3a-bb1f-ecd92df2e5dd 36 fields · synced May 30, 2026
- EUDAMED d26391d5-d687-4430-b67a-6666ad58c93c 61 fields · synced Jun 14, 2026