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IM reamer shaft dove tail 470 mm, Hudson coup.
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref T3713Model IM Reamer Shaft
Identity
- Trade Name
- IM reamer shaft dove tail 470 mm, Hudson coup. EUDAMEDFDA UDI
- Generic Name
- Medullary canal orthopaedic reamer, flexible FDA UDI
- Device Name
- The Intramedullary reamer shaft is used in combination with the Intramedullary reamer head to ream the medullary cavity of long bones in traumatologic or limb lengthening surgery of the femur, tibia and humerus bones where medullary cavities need to be prepared prior to placing a nail.The intramedullary reamers are intended for use with a guide wire to permit to secure the assembly and a surgical drilling machine. A range of models is proposed in regards with the nail to be implanted. Different coupling are available to connect the shaft with existing power tool. The device is reusable. FDA UDI
- Model / Reference
- IM Reamer Shaft EUDAMEDT3713 EUDAMEDFDA UDI
- Description
- The Intramedullary reamer shaft is used in combination with the Intramedullary reamer head to ream the medullary cavity of long bones in traumatologic or limb lengthening surgery of the femur, tibia and humerus bones where medullary cavities need to be prepared prior to placing a nail.The intramedullary reamers are intended for use with a guide wire to permit to secure the assembly and a surgical drilling machine. A range of models is proposed in regards with the nail to be implanted. Different coupling are available to connect the shaft with existing power tool. The device is reusable. FDA UDI
Identifiers
- Catalog Number
- T3713 FDA UDI
- Primary DI / UDI-DI
- 07640187911695 EUDAMEDFDA UDI
- Basic UDI-DI
- 764018791IMREAMSHAFT01G4 EUDAMED
- Direct Marketing DI
- 07640187911695 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- Z12130580 MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - HARDWARE ACCESSORIES 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
IM reamer shaft dove tail 470 mm, Hudson coup. by MPS Micro Precision Systems AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 764018791IMREAMSHAFT01G4 | 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 (2)
- EUDAMED 4ba53879-69e7-4d0d-8ee2-eb963e3b4f60 61 fields · synced Jun 8, 2026
- FDA UDI 990acea6-0227-45ab-bdd6-7a30c535c00e 35 fields · synced May 30, 2026