Identity
- Trade Name
- DUALTO Energy System FDA UDI
- Generic Name
- Electrosurgical/ultrasonic surgical system tester interface FDA UDI
- Device Name
- GEN11 Key EUDAMEDEthicon Energy Output Verification Key FDA UDI
- Model / Reference
- G11SWK EUDAMEDETHOVK EUDAMEDFDA UDI
- Description
- Ethicon Energy Output Verification Key FDA UDI
Identifiers
- Catalog Number
- ETHOVK FDA UDI
- Primary DI / UDI-DI
- 20705036013942 EUDAMED20705036039287 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705036a000186R EUDAMED
- Direct Marketing DI
- 10705036039280 EUDAMED
- 510(k) Number
- K243067 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- Z12010980 ELECTROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electrosurgical/ultrasonic surgical system tester interface 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
GEN11 Key by Ethicon Endo-Surgery, LLC — 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 | 0705036a000186R | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, LLC
- EUDAMED SRN
- US-MF-000013107
- Authorised Representative
- Johnson & Johnson Medical GmbH DE-AR-000007712
Sources (3)
- EUDAMED 14443ef1-fa09-4856-844b-d9dc296e2dc5 61 fields · synced Jul 17, 2026
- FDA UDI efcaf035-3035-45e1-a8d3-5ff5bfed0938 37 fields · synced May 30, 2026
- EUDAMED 7b660e90-1569-4324-9e05-8e072a77f22b 61 fields · synced Jul 17, 2026