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Femoral IM reamer Ø8 x 475 mm, can. Ø3.1 mm Hudson coup.
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref T6412Model IM Reamer MonoblocRef T15123Ref T18189
Identity
- Trade Name
- Femoral IM reamer Ø8 x 475 mm, can. Ø3.1 mm Hudson coup. EUDAMEDFDA UDIFemoral IM reamer Ø8 x 475 mm, can. Ø3.1 mm Big AO coup. EUDAMEDFemoral IM reamer Ø8 x 475 mm, can. Ø3.1 mm Stryker/Zimmer-Hall coup. EUDAMEDFDA UDI
- Generic Name
- Medullary canal orthopaedic reamer, flexible FDA UDI
- Device Name
- Femoral monobloc intramedullary reamer is used to ream the medullary cavity of femoral bone prior to placing a nail. A range of diameter is proposed in regards with the nail to be implanted and a range of length is proposed in regards with the height of the bone. Different distal coupling are available to connect with existing power tool. FDA UDI
- Model / Reference
- IM Reamer Monobloc EUDAMEDT6412 EUDAMEDFDA UDIT15123 EUDAMEDT18189 EUDAMEDFDA UDI
- Description
- Femoral monobloc intramedullary reamer is used to ream the medullary cavity of femoral bone prior to placing a nail. A range of diameter is proposed in regards with the nail to be implanted and a range of length is proposed in regards with the height of the bone. Different distal coupling are available to connect with existing power tool. FDA UDI
Identifiers
- Catalog Number
- T18189 FDA UDIT6412 FDA UDI
- Primary DI / UDI-DI
- 07640187911886 EUDAMEDFDA UDI07640187911497 EUDAMED07640187912098 EUDAMEDFDA UDI
- Basic UDI-DI
- 764018791IMREAMMONO01DH EUDAMED
- Direct Marketing DI
- 07640187911886 EUDAMED07640187911497 EUDAMED07640187912098 EUDAMED
- FDA Product Code
- HTO FDA UDI
- EMDN Code
- L091102 ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE EUDAMED
- GMDN Term
- Medullary canal orthopaedic reamer, flexible 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
Femoral IM reamer Ø8 x 475 mm, can. Ø3.1 mm Hudson coup. by MPS Micro Precision Systems AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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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 | 764018791IMREAMMONO01DH | 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 (5)
- EUDAMED 3f3ac114-69f1-4e3a-a92f-b066c0c184bd 61 fields · synced Oct 6, 2026
- EUDAMED 3cdc1dfb-5b6f-4928-bc0c-2860e8b3a4a0 61 fields · synced May 18, 2026
- FDA UDI 17347c17-4cde-43fe-a346-07fb5cf6cebd 35 fields · synced May 30, 2026
- FDA UDI 48f8846d-6251-4ad5-8a18-3bd7a8cf51c5 35 fields · synced May 30, 2026
- EUDAMED 20133015-da23-4a36-b6b5-2e4d9a7a4f72 61 fields · synced Jul 9, 2026