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Offset reamer handle - Large AO motor shaft
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref S03271
Identity
- Trade Name
- Offset reamer handle - Large AO motor shaft EUDAMEDFDA UDI
- Generic Name
- Surgical power tool adaptor FDA UDI
- Device Name
- Offset Reamer Handle EUDAMEDOffset Reamer Handle power coupling accessory FDA UDI
- Model / Reference
- S03271 EUDAMED50244506 FDA UDI
- Description
- Offset Reamer Handle power coupling accessory FDA UDI
Identifiers
- Catalog Number
- 10-502-457-06 FDA UDI
- Primary DI / UDI-DI
- 07630055305718 EUDAMEDFDA UDI
- Basic UDI-DI
- 7630055300502445ORHBT EUDAMED
- Direct Marketing DI
- 07630055305718 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical power tool adaptor FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Austria 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
Offset reamer handle - Large AO motor shaft by Incipio Devices SA — Class IIa — 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 | 7630055300502445ORHBT | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 2396805a-9e1a-4786-969c-cc0547ec4e1b 61 fields · synced Jul 11, 2026
- FDA UDI 410e24f4-5824-4094-8386-4ccc0c232a12 34 fields · synced May 30, 2026