Identity
- Trade Name
- Ellex FDA UDI
- Generic Name
- Foot-switch, electrical FDA UDI
- Device Name
- ACC. FOOTSWITCH, TANGO/ULTRAQ FDA UDI
- Model / Reference
- 6336540 FDA UDI
- Description
- ACC. FOOTSWITCH, TANGO/ULTRAQ FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09342395000649 FDA UDI
- FDA Product Code
- GEX FDA UDIHQF FDA UDI
- GMDN Term
- Foot-switch, electrical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI886.4390 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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: Foot-switch, electrical
Ellex by Ellex Medical Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K021550 also covers:
K992824 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ellex Medical Pty Ltd
Sources (1)
- FDA UDI 7181c60f-dcb5-437c-98e3-1b356315089d 35 fields · synced May 30, 2026