Identity
- Trade Name
- DUALTO Energy System FDA UDI
- Generic Name
- Foot-switch, electrical FDA UDI
- Device Name
- Footswitch G11 EUDAMEDEnergy Single Footswitch FDA UDI
- Model / Reference
- ETHEF1 EUDAMEDFDA UDI
- Description
- Energy Single Footswitch FDA UDI
Identifiers
- Catalog Number
- ETHEF1 FDA UDI
- Primary DI / UDI-DI
- 20705036038402 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705036a000196T EUDAMED
- Direct Marketing DI
- 10705036038405 EUDAMED
- 510(k) Number
- K243067 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- Z12010980 ELECTROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Foot-switch, electrical FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 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: Foot-switch, electrical
DUALTO Energy System by Ethicon Endo-Surgery, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, Inc.
Sources (2)
- FDA UDI 8e319fea-e6ba-412a-8b72-9cc42f415a71 37 fields · synced Jun 19, 2026
- EUDAMED 8c7e609d-495a-448d-ab2c-57bc533133e7 61 fields · synced Jun 19, 2026