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Torque Wrench
EUDAMEDFDA UDIClass I (EU MDR)
Ref 5450-800-039Model 08858251004511SW
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Ultrasonic surgical system torque wrench, reusable FDA UDI
- Device Name
- Torque Wrench EUDAMEDStep Torque Wrench, 7 mm FDA UDI
- Model / Reference
- 08858251004511SW EUDAMED5450-800-039 EUDAMED5450800039 FDA UDI
- Description
- Step Torque Wrench, 7 mm FDA UDI
Identifiers
- Catalog Number
- 5450-800-039 FDA UDI
- Primary DI / UDI-DI
- 07613327291513 EUDAMEDFDA UDI
- Basic UDI-DI
- 08858251004511SW EUDAMED
- Direct Marketing DI
- 07613327291513 EUDAMED
- FDA Product Code
- MDM FDA UDI
- EMDN Code
- Z12010880 INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Ultrasonic surgical system torque wrench, reusable 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Ultrasonic surgical system generator
Torque Wrench by Stryker Instruments — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 08858251004511SW | 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 511439a0-00f2-4536-b5cb-b5795f293795 61 fields · synced Jun 18, 2026
- FDA UDI 1fd76f9a-39d1-4b45-8a9f-d13f824a23fe 35 fields · synced May 30, 2026