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Humeral IM reamer Ø7 x 343 mm, can. Ø2.3 mm, Big AO coup.
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref T4868Model IM Reamer MonoblocRef T7643
Identity
- Trade Name
- Humeral IM reamer Ø7 x 343 mm, can. Ø2.3 mm, Big AO coup. EUDAMEDFDA UDIHumeral IM reamer Ø7 x 343 mm, can. Ø2.3 mm, Stryker/Zimmer-Hall 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 EUDAMEDT4868 EUDAMEDFDA UDIT7643 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
- T4868 FDA UDIT7643 FDA UDI
- Primary DI / UDI-DI
- 07640187911381 EUDAMEDFDA UDI07640187915693 EUDAMEDFDA UDI
- Basic UDI-DI
- 764018791IMREAMMONO01DH EUDAMED
- Direct Marketing DI
- 07640187911381 EUDAMED07640187915693 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
Humeral IM reamer Ø7 x 343 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 c65c2930-5752-4e48-91c6-77ace0af57f4 61 fields · synced Aug 2, 2026
- FDA UDI a06402c2-eaa3-4bdd-8cd8-b3c42daed756 35 fields · synced May 30, 2026
- FDA UDI 5b3a7c6a-9804-45dd-97c1-c01c539823d5 35 fields · synced May 30, 2026
- EUDAMED c467fb64-71c4-4d7b-972e-14a7ab7d0ea9 61 fields · synced Jul 26, 2026