Humeral IM reamer Ø6.5 x 341 mm, can. Ø2.3 mm, Stryker/Zimmer-Hall coup.
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Humeral IM reamer Ø6.5 x 341 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
- T7642 EUDAMEDFDA UDIIM Reamer Monobloc EUDAMED
- 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
- T7642 FDA UDI
- Primary DI / UDI-DI
- 07640187915686 EUDAMEDFDA UDI
- Basic UDI-DI
- 764018791IMREAMMONO01DH EUDAMED
- Direct Marketing DI
- 07640187915686 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
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Medullary canal orthopaedic reamer, flexible
Humeral IM reamer Ø6.5 x 341 mm, can. Ø2.3 mm, Stryker/Zimmer-Hall coup. by MPS Micro Precision Systems AG — Class I — MDR, FDA UDI — listed in FDA GUDID…
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- MPS Micro Precision Systems AG
Sources (2)
- FDA UDI 999a58b0-10a6-4140-8c33-7dd74d2958ea 35 fields · synced Oct 5, 2026
- EUDAMED 8d0e36d1-81ee-428f-8b94-32997ecbcdd6 61 fields · synced Oct 5, 2026