Identity
- Trade Name
- Sonopet EUDAMEDFDA UDI
- Generic Name
- Electromechanical device/system transport trolley FDA UDI
- Device Name
- Transport Carts EUDAMEDCart FDA UDI
- Model / Reference
- 08858250000639SC EUDAMED5450-850-410 EUDAMED5450850410 FDA UDI
- Description
- Cart FDA UDI
Identifiers
- Catalog Number
- 5450-850-410 FDA UDI
- Primary DI / UDI-DI
- 07613252031352 EUDAMEDFDA UDI
- Basic UDI-DI
- 08858250000639SC EUDAMED
- Direct Marketing DI
- 07613252031352 EUDAMED
- FDA Product Code
- MDM FDA UDI
- EMDN Code
- Z12010880 INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electromechanical device/system transport trolley FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Netherlands 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Sonopet by Stryker Instruments — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 08858250000639SC | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Stryker Instruments
- EUDAMED SRN
- US-MF-000025219
- Authorised Representative
- Stryker European Operations Limited IE-AR-000000092
Sources (2)
- EUDAMED 7ff15256-80e8-407d-9c8b-0ba6f7e10ab8 61 fields · synced Jul 17, 2026
- FDA UDI ab64eccd-f267-4198-9784-efdccbe047d1 35 fields · synced May 30, 2026