Identity
- Trade Name
- CONMED EUDAMEDFDA UDI
- Generic Name
- VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - OTHER EUDAMEDFoot-switch, electrical FDA UDI
- Device Name
- Orthopedic, Non-active, Accessory, Footswitch, Wireless EUDAMEDRESECTION WIRELESS FOOT CONTROL FDA UDI
- Model / Reference
- W2000 EUDAMEDFDA UDI
- Description
- RESECTION WIRELESS FOOT CONTROL FDA UDI
Identifiers
- Catalog Number
- W2000 FDA UDI
- Primary DI / UDI-DI
- 20845854050313 EUDAMEDFDA UDI
- Basic UDI-DI
- 084585408588E5 EUDAMED
- Direct Marketing DI
- 10845854050316 EUDAMED
- 510(k) Number
- K083161 FDA UDI
- FDA Product Code
- HRX FDA UDI
- EMDN Code
- Z129099 VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - OTHER EUDAMED
- GMDN Term
- Foot-switch, electrical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Legislation / Framework
- MDR (REGULATION (EU) 2017/745 on medical devices) EUDAMED
- Regulation Number
- 888.1100 FDA UDI
- Market of Registration
- Belgium 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Fixture/appliance dental drill bit, reusable
Conmed by Conmed Corporation — 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 | 084585408588E5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
- EUDAMED SRN
- US-MF-000012663
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 67 fields · synced Jun 6, 2026
- FDA UDI 8a2b8eea-8524-4f1e-a17e-86d316664814 37 fields · synced May 30, 2026