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Orientable Alignment Guide - Lateral 20°/45°
EUDAMEDFDA UDIClass I (EU MDR)
Ref 50340170Ref SSI006236
Identity
- Trade Name
- Orientable Alignment Guide - Lateral 20°/45° EUDAMEDFDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- Orientable Alignment Guide EUDAMEDAlignment guide accessory of Offset Cup Impactor FDA UDI
- Model / Reference
- 50340170 EUDAMEDFDA UDISSI006236 EUDAMED
- Description
- Alignment guide accessory of Offset Cup Impactor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630055303042 EUDAMEDFDA UDI07630055303189 EUDAMED
- Basic UDI-DI
- 7630055300503401OAG8F EUDAMED
- Direct Marketing DI
- 07630055303042 EUDAMED07630055303189 EUDAMED
- FDA Product Code
- HWA FDA UDI
- EMDN Code
- L0922 ORTHOPAEDIC SURGERY GUIDES, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 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
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
Orientable Alignment Guide - Lateral 20°/45° 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 | 7630055300503401OAG8F | 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 (3)
- EUDAMED ea5b3d0f-f1bf-4e2e-b0e0-e1b540254347 61 fields · synced Jun 20, 2026
- EUDAMED 69c45d83-73b1-48ce-bab5-aead888caf9e 61 fields · synced May 18, 2026
- FDA UDI 85acba11-36d3-4ea1-885f-c85904b427af 33 fields · synced May 29, 2026