Acetabular reamer Ø76 with round tooth
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Acetabular reamer Ø76 with round tooth EUDAMEDFDA UDI
- Generic Name
- Acetabular orthopaedic reamer FDA UDI
- Device Name
- Acetabular reamer for hip arthroplasty FDA UDI
- Model / Reference
- T18249 EUDAMEDFDA UDIT18050 EUDAMEDFDA UDIAcetabular reamer EUDAMED
- Description
- Acetabular reamer for hip arthroplasty FDA UDI
Identifiers
- Catalog Number
- T18249 FDA UDIT18050 FDA UDI
- Primary DI / UDI-DI
- 07640187912692 EUDAMEDFDA UDI07640187913590 EUDAMEDFDA UDI
- Basic UDI-DI
- 764018791REAMACETAB01SP EUDAMED
- Direct Marketing DI
- 07640187912692 EUDAMED07640187913590 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
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Acetabular orthopaedic reamer
Acetabular reamer Ø76 with round tooth by MPS Micro Precision Systems AG — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
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
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- MPS Micro Precision Systems AG
Sources (4)
- FDA UDI 5b8e3465-7b81-47a5-a977-9d6ecd19e568 35 fields · synced Sep 30, 2026
- FDA UDI 7ed0a216-6766-48d5-9a01-465548774ca0 35 fields · synced May 29, 2026
- EUDAMED a5f4810e-77b4-4d1b-a621-4cf0d24d3ee2 61 fields · synced Jul 10, 2026
- EUDAMED 4cbe3772-6a99-439a-824b-99904e0ef476 61 fields · synced Sep 17, 2026