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Acetabular reamer Ø62 with round tooth
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref T17819Model Acetabular reamerRef T18235
Identity
- Trade Name
- Acetabular reamer Ø62 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 EUDAMEDT17819 EUDAMEDFDA UDIT18235 EUDAMEDFDA UDI
- Description
- Acetabular reamer for hip arthroplasty FDA UDI
Identifiers
- Catalog Number
- T18235 FDA UDIT17819 FDA UDI
- Primary DI / UDI-DI
- 07640187913002 EUDAMEDFDA UDI07640187912555 EUDAMEDFDA UDI
- Basic UDI-DI
- 764018791REAMACETAB01SP EUDAMED
- Direct Marketing DI
- 07640187913002 EUDAMED07640187912555 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 Ø62 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 59095def-b182-4bad-b63c-b9a1655b30a0 61 fields · synced Jul 29, 2026
- FDA UDI 3d21b59d-687d-41f7-a244-0eee605a7b68 35 fields · synced May 30, 2026
- FDA UDI fc8ed02a-5e81-497a-a381-bb84186d56b0 35 fields · synced May 30, 2026
- EUDAMED 252d9ecf-f69d-4ecc-805a-57a07423b278 61 fields · synced Jul 10, 2026