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Humeral IM reamer Ø8 x 345 mm, can. Ø2.3 mm, Big AO coup.
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref T4870Model IM Reamer MonoblocRef T14038Ref T7645
Identity
- Trade Name
- Humeral IM reamer Ø8 x 345 mm, can. Ø2.3 mm, Big AO coup. EUDAMEDFDA UDIHumeral IM reamer Ø8 x 345 mm, can. Ø2.3 mm, Stryker/Zimmer-Hall coup. EUDAMEDFDA UDIHumeral IM reamer Ø8 x 345 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 EUDAMEDT4870 EUDAMEDFDA UDIT7645 EUDAMEDFDA UDIT14038 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
- T7645 FDA UDIT14038 FDA UDIT4870 FDA UDI
- Primary DI / UDI-DI
- 07640187911404 EUDAMEDFDA UDI07640187915716 EUDAMEDFDA UDI07640187917581 EUDAMEDFDA UDI
- Basic UDI-DI
- 764018791IMREAMMONO01DH EUDAMED
- Direct Marketing DI
- 07640187911404 EUDAMED07640187917581 EUDAMED07640187915716 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 UDIFDA UDI
Moist Heat or Steam Sterilization FDA UDI
Humeral IM reamer Ø8 x 345 mm, can. Ø2.3 mm, Big AO 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 | 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 (6)
- EUDAMED 463aeb00-cb87-4410-9ebc-455f7e2b514e 61 fields · synced Oct 6, 2026
- FDA UDI 0e7be27f-2a0e-416d-9132-42cf54f0b403 35 fields · synced May 29, 2026
- FDA UDI 8450895d-17dd-4726-8f57-693572803814 34 fields · synced May 30, 2026
- FDA UDI a344ed04-d018-45e0-8445-e68f87bf3329 35 fields · synced May 30, 2026
- EUDAMED 32c1a27b-3a86-4040-8362-267f98ff9cf4 61 fields · synced Jul 8, 2026
- EUDAMED 74137812-5c97-4508-baf9-f8c93f3927ca 61 fields · synced Jul 15, 2026