Identity
- Trade Name
- ACE Acetabular Reamer ø54mm EUDAMEDACE Acetabular Reamer 54mm FDA UDI
- Generic Name
- Acetabular orthopaedic reamer FDA UDI
- Device Name
- MIM Acetabular Reamer EUDAMEDAcetabular Reamer FDA UDI
- Model / Reference
- 50141054 EUDAMEDFDA UDI
- Description
- Acetabular Reamer FDA UDI
Identifiers
- Catalog Number
- 00-501-410-54 FDA UDI
- Primary DI / UDI-DI
- 07630055305435 EUDAMEDFDA UDI
- Basic UDI-DI
- 7630055300501410REA7Y EUDAMED
- Direct Marketing DI
- 07630055305435 EUDAMED
- FDA Product Code
- HTO FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Acetabular orthopaedic reamer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- France 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
Dimensions & Sizes
- Size
- Outer Diameter — 54 Millimeter FDA UDI
ACE Acetabular Reamer ø54mm 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 | 7630055300501410REA7Y | 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 359a663e-6b76-4bc4-8ab1-3e10bc7b056b 61 fields · synced Aug 1, 2026
- FDA UDI d251395d-3e0c-4c85-a52d-e3de22dd260a 35 fields · synced May 30, 2026