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Offset reamer handle - Stryker Z/H - Dual coupling
EUDAMEDClass IIa (EU MDR)
Ref 50244502
Identity
- Trade Name
- Offset reamer handle - Stryker Z/H - Dual coupling EUDAMED
- Device Name
- Offset Reamer Handle EUDAMED
- Model / Reference
- 50244502 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630055305770 EUDAMED
- Basic UDI-DI
- 7630055300502445ORHBT EUDAMED
- Direct Marketing DI
- 07630055305770 EUDAMED
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
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
The Offset Reamer Handle - Stryker Z/H - Dual Coupling device is a medical device designed for precision reaming operations. This Class IIa device features a dual coupling mechanism, allowing for precise control over the reamming process. The device's sterile design and self-testing capabilities ensure accurate and reliable results.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7630055300502445ORHBT | Class IIa | Active |
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Manufacturer
- Manufacturer
- Incipio Devices SA
- EUDAMED SRN
- CH-MF-000030518
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 133c7115-6dcc-40d5-8738-fb9dc4d7539b 61 fields · synced Jun 24, 2026