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Positioning Handle - 3/8-16 interface
EUDAMEDFDA UDIClass I (EU MDR)
Ref 50341134Model 50340100
Identity
- Trade Name
- Positioning Handle - 3/8-16 interface EUDAMEDFDA UDI
- Generic Name
- Orthopaedic implant impactor, reusable FDA UDI
- Device Name
- Offset Cup Impactor EUDAMEDPositioning handle assembly accessory for offset cup impactor 3/8-16 interface FDA UDI
- Model / Reference
- 50340100 EUDAMED50341134 EUDAMEDFDA UDI
- Description
- Positioning handle assembly accessory for offset cup impactor 3/8-16 interface FDA UDI
Identifiers
- Catalog Number
- 10-503-411-34 FDA UDI
- Primary DI / UDI-DI
- 07630055304742 EUDAMEDFDA UDI
- Basic UDI-DI
- 7630055300503401OCI8R EUDAMED
- Direct Marketing DI
- 07630055304742 EUDAMED
- FDA Product Code
- HWA FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic implant impactor, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
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
Positioning Handle - 3/8-16 interface by Incipio Devices SA — 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 | 7630055300503401OCI8R | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Incipio Devices SA
- EUDAMED SRN
- CH-MF-000030518
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 770cc032-cf4d-4772-aaf1-6c0735775d25 61 fields · synced Jun 20, 2026
- FDA UDI c4a685fb-1d04-4e82-9074-0db191c023a9 34 fields · synced May 30, 2026