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Modular needle holder handles
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8393.941Model 10000201261
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Suturing needle holder, reusable FDA UDI
- Device Name
- Modular needle holder handles EUDAMEDNEEDLE HOLDER HANDLE AXIAL with locking mechanism, non-rotatable, for use with needle holder, Moduline and RIWO-GRIP sheath tubes, reusable FDA UDI
- Model / Reference
- 10000201261 EUDAMED8393.941 EUDAMED8393941 FDA UDI
- Description
- NEEDLE HOLDER HANDLE AXIAL with locking mechanism, non-rotatable, for use with needle holder, Moduline and RIWO-GRIP sheath tubes, reusable FDA UDI
Identifiers
- Catalog Number
- 8393.941 FDA UDI
- Primary DI / UDI-DI
- 04055207016343 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520727052019-0018260P6 EUDAMED
- Direct Marketing DI
- 04055207016343 EUDAMED
- FDA Product Code
- FHQ FDA UDI
- EMDN Code
- L1205 LAPAROSCOPIC AND THORACOSCOPIC SURGERY NEEDLE HOLDERS, REUSABLE EUDAMED
- GMDN Term
- Suturing needle holder, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.4730 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
No
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
Yes
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
Modular needle holder handles by Richard Wolf GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 405520727052019-0018260P6 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Richard Wolf GmbH
- EUDAMED SRN
- DE-MF-000007048
Sources (2)
- EUDAMED 9b9c1e52-8a86-4665-9668-758d39d9f5f5 61 fields · synced Sep 18, 2026
- FDA UDI b3a4b9f1-fe74-4523-9b6a-aca80461abe3 35 fields · synced May 29, 2026