FDA.reportPublic FDA data

DUALTO Energy System

Primary DI
20705036038426
Brand
DUALTO Energy System
Company
ETHICON ENDO-SURGERY, LLC
Model
ETHCRT
Catalog number
ETHCRT
Device description
DUALTO Energy Cart
Published
2025-06-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, cutting & coagulation & accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243067000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243067000The ETHICON™ Total Energy SystemEthicon Endo-Surgery, LLC (A Johnson and Johnson Company)2025-01-17GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705036038429Direct MarkingGS10
30705036038423PackageGS11In Commercial Distribution
20705036038426PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503603842910705036038429
3070503603842330705036038423
2070503603842620705036038426

GMDN Terms#

Term, Definition table
TermDefinition
Electromechanical device/system transport trolleyA mobile (on wheels) cart intended to be used as a carrier for transporting an electromechanical device(s) or a powered system assembly. This trolley (cart) may be designed specifically for a proprietary control unit/system, and will typically have one or more horizontal surfaces where the devices are placed; it may include additional features (e.g., gas cylinder holder, intravenous pole) specific to a proprietary system. Neither electromechanical devices nor system components are included.

Contacts#

Phone, Email table
PhoneEmail
+1(877)384-4266customersupport@eesus.jnj.com

Regulatory Flags#

DUNS number
044606982
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705036046523Megadyne2255JTES2255JTES2026-05-27
10705036003113HARMONICTLB01TLB012016-07-15
20705036003271HARMONICTTBLUETTBLUE2016-07-15
20705036013904N/ACRT11CRT112016-07-15
20705036038396DUALTO Energy SystemETHEF2ETHEF22025-06-18
20705036038402DUALTO Energy SystemETHEF1ETHEF12025-06-18
20705036038419DUALTO Energy SystemETHERFETHERF2025-06-18
20705036039287DUALTO Energy SystemETHOVKETHOVK2025-06-20
20705036038365DUALTO Energy SystemETHCMETHCM2025-06-18
20705036038372DUALTO Energy SystemETHUSCETHUSC2025-06-18
20705036038389DUALTO Energy SystemETHEMETHEM2025-06-18
10705036013143ProximateTCT55TCT552015-08-24
10705036013204PROXIMATETLC55TLC552015-08-24
10705036013006ProximatePPH03PPH032015-08-24
10705036013112ProximateTCD75TCD752015-08-24
10705036013150PROXIMATETCT75TCT752015-08-24
10705036013211PROXIMATETLC75TLC752015-08-24
10705036013389PROXIMATETVC55TVC552015-08-24
10705036002895ETHIBOND; DURAKNOTSW110SW1102016-07-15
10705036002901ETHIBOND; DURAKNOTSW112SW1122016-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846338006044Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006051Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006068Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006082Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006099Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006105Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006112Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006129Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006136Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006143Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006150Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006167Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006174Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006181Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006198Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006204Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006211Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006228Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006235Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006242Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006259Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006266Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006273Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006310Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006341Triple Footswitch & CableELLIQUENCE, LLCGEI2026-06-02
00846338007133Trigger-Flex Quad Pro Bipolar SystemELLIQUENCE, LLCGEI2026-06-02
00846338007140BiPolar Cable, DisposableELLIQUENCE, LLCGEI2026-06-02
00846338004712Monopolar ElectrodeELLIQUENCE, LLCGEI2026-06-01
00846338004729Monopolar ElectrodeELLIQUENCE, LLCGEI2026-06-01
00846338004736Monopolar ElectrodeELLIQUENCE, LLCGEI2026-06-01