FDA.reportPublic FDA data

N/A

Primary DI
20705036013959
Brand
N/A
Company
ETHICON ENDO-SURGERY, LLC
Model
GEN11
Catalog number
GEN11
Device description
Generator G11
Published
2016-07-15
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705036013952Direct MarkingGS10
20705036013959PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503601395210705036013952
2070503601395920705036013959

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical/ultrasonic surgical system generatorA mains electricity-powered (AC-powered) device designed to provide high frequency electrical current to power connected electrosurgical diathermy instruments (create heat within tissues) and ultrasonic surgical instruments (rapidly vibrate tissues), enabling a combination of methods to cut and/or coagulate tissues during open or laparoscopic surgery; the instruments are not included. The device may be used for various types of surgery (e.g., general, gynaecological, plastic); it is typically regulated by the operator with a hand- or foot-switch.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-35 Degrees Celsius54 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
044606982
Device count
1
Serial number
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
20705036038426DUALTO Energy SystemETHCRTETHCRT2025-06-18
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

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Primary DI, Brand, Company table
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08886479300306RhinAer+ StylusAerin Medical Inc.GEI2025-09-19
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07613327548204Neptune SafeAirSTRYKER CORPORATIONGEI2025-01-06
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07613327548129NeptuneSTRYKER CORPORATIONGEI2024-12-10
07613327548143NeptuneSTRYKER CORPORATIONGEI2024-12-10