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Straight reamer handle - Stryker Z/H - Tri coupling
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 50245161Model Straight Reamer HandleRef 50244561
Identity
- Trade Name
- Straight reamer handle - Stryker Z/H - Tri coupling EUDAMEDStraight reamer handle - Stryker Z/H - Tri-coupling FDA UDI
- Generic Name
- Surgical power tool adaptor FDA UDI
- Device Name
- Straight Reamer Handle EUDAMEDStraight Reamer Handle for hip arthroplasty FDA UDI
- Model / Reference
- Straight Reamer Handle EUDAMED50245161 EUDAMED50244561 EUDAMEDFDA UDI
- Description
- Straight Reamer Handle for hip arthroplasty FDA UDI
Identifiers
- Catalog Number
- 50244561 FDA UDI
- Primary DI / UDI-DI
- 07630055307088 EUDAMED07630055306111 EUDAMED07630055301949 FDA UDI
- Basic UDI-DI
- 7630055300502445SRHCF EUDAMED
- Direct Marketing DI
- 07630055307088 EUDAMED07630055306111 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical power tool adaptor FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
Straight reamer handle - Stryker Z/H - Tri coupling by Incipio Devices SA — 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 | 7630055300502445SRHCF | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Incipio Devices SA
- EUDAMED SRN
- CH-MF-000030518
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED 004decbd-fa77-4871-ba08-258eafdb625c 61 fields · synced Aug 4, 2026
- EUDAMED 02c4f0c1-c6e6-4356-9616-6d950bd4697a 61 fields · synced May 18, 2026
- FDA UDI 79646339-12ca-4cac-86be-bd6383c4ea7d 34 fields · synced May 27, 2026