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Acetabular reamer Ø40 with round tooth
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref T17797Model Acetabular reamerRef T18213
Identity
- Trade Name
- Acetabular reamer Ø40 with round tooth EUDAMEDFDA UDI
- Generic Name
- Acetabular orthopaedic reamer FDA UDI
- Device Name
- Acetabular reamer for hip arthroplasty FDA UDI
- Model / Reference
- Acetabular reamer EUDAMEDT17797 EUDAMEDFDA UDIT18213 EUDAMEDFDA UDI
- Description
- Acetabular reamer for hip arthroplasty FDA UDI
Identifiers
- Catalog Number
- T17797 FDA UDIT18213 FDA UDI
- Primary DI / UDI-DI
- 07640187912784 EUDAMEDFDA UDI07640187912333 EUDAMEDFDA UDI
- Basic UDI-DI
- 764018791REAMACETAB01SP EUDAMED
- FDA Product Code
- HTO FDA UDI
- EMDN Code
- L091102 ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE 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
- 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
Category: Acetabular orthopaedic reamer
Acetabular reamer Ø40 with round tooth by MPS Micro Precision Systems AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Also classified as Acetabular orthopaedic reamer.
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- iTotal® Hip Replacement System — Conformis, Inc. · Class II
- M.B.T. — DePuy Ireland UC · Class IIa
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 | 764018791REAMACETAB01SP | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- MPS Micro Precision Systems AG
- EUDAMED SRN
- CH-MF-000032439
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (4)
- EUDAMED d1b48f63-4339-425b-8a32-49cf11dc48fc 61 fields · synced Sep 17, 2026
- FDA UDI 93bebc45-fcaa-4c58-9f7c-3041f5e6cafd 35 fields · synced May 29, 2026
- FDA UDI 7972dcec-22e7-4242-9764-37c9fa61ff40 35 fields · synced May 29, 2026
- EUDAMED 49584561-daa3-4ded-884d-cae1df292e67 61 fields · synced Sep 17, 2026