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Humeral IM reamer Ø9.5 x 347 mm, can. Ø2.3 mm, Big AO coup.
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref T5357Model IM Reamer MonoblocRef T14041
Identity
- Trade Name
- Humeral IM reamer Ø9.5 x 347 mm, can. Ø2.3 mm, Big AO coup. EUDAMEDFDA UDIHumeral IM reamer Ø9.5 x 347 mm, can. Ø2.3 mm Hudson coup. EUDAMEDFDA UDI
- Generic Name
- Medullary canal orthopaedic reamer, flexible FDA UDI
- Device Name
- Humeral monobloc intramedullary reamer is used to ream the medullary cavity of humeral 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. This is a reusable device. FDA UDI
- Model / Reference
- IM Reamer Monobloc EUDAMEDT5357 EUDAMEDFDA UDIT14041 EUDAMEDFDA UDI
- Description
- Humeral monobloc intramedullary reamer is used to ream the medullary cavity of humeral 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. This is a reusable device. FDA UDI
Identifiers
- Catalog Number
- T14041 FDA UDIT5357 FDA UDI
- Primary DI / UDI-DI
- 07640187911435 EUDAMEDFDA UDI07640187917826 EUDAMEDFDA UDI
- Basic UDI-DI
- 764018791IMREAMMONO01DH EUDAMED
- Direct Marketing DI
- 07640187911435 EUDAMED07640187917826 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
No
FDA UDIFDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Acetabular orthopaedic reamer
Humeral IM reamer Ø9.5 x 347 mm, can. Ø2.3 mm, Big AO coup. 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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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 (4)
- EUDAMED c69e2ab3-1b3d-42e1-b555-7cf83b329a8f 61 fields · synced Oct 6, 2026
- FDA UDI 2b86c6dc-64b3-417a-a0bb-d7cae939dc97 34 fields · synced May 29, 2026
- FDA UDI d8c26713-80b8-4706-b3c8-9ebd1261e6b1 35 fields · synced May 30, 2026
- EUDAMED 4367afe0-8230-4564-83f6-f1f938fb4a2e 61 fields · synced Sep 17, 2026