Identity
- Trade Name
- DUALTO Energy System FDA UDI
- Generic Name
- Electrosurgical/ultrasonic surgical system generator FDA UDI
- Device Name
- Ethicon User Screen FDA UDI
- Model / Reference
- ETHUSC FDA UDI
- Description
- Ethicon User Screen FDA UDI
Identifiers
- Catalog Number
- ETHUSC FDA UDI
- Primary DI / UDI-DI
- 20705036038372 FDA UDI
- 510(k) Number
- K243067 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Electrosurgical/ultrasonic surgical system generator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
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: Electrosurgical/ultrasonic surgical system generator
DUALTO Energy System by Ethicon Endo-Surgery, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrosurgical/ultrasonic surgical system generator.
- FMX — Domain Surgical, Inc. · Class II
- Varicure — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · Class II
- ULTRASONIC BIPOLAR GENERATOR — Olympus Medical Systems Corporation · Class II
- Handlike — Hunan Handlike Minimally Invasive Surgery Co., Ltd. · U
- Varicure — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · Class II
- DUALTO Energy System — ETHICON ENDO-SURGERY, INC. · Class II
- DUALTO Energy System — ETHICON ENDO-SURGERY, INC. · Class II
Cleared under the same submission
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
- Ethicon Endo-Surgery, Inc.
Sources (1)
- FDA UDI ea491df0-662d-4c51-a870-32d7101c2a9d 37 fields · synced Jun 8, 2026