FDA.reportPublic FDA data

FMX

Primary DI
00859729006004
Brand
FMX
Company
DOMAIN SURGICAL, INC.
Model
G1
Catalog number
FMG1
Device description
FMX G1 Generator
Published
2016-06-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K110439000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110439000DOMAIN SURGICAL SYSTEMDomain Surgical, Inc.2011-07-18GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859729006004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859729006004008597290060048597290060040859729006004

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical system generatorA mains electricity-powered (AC-powered) component of a electrosurgical system intended to generate radio-frequency (RF) electrical current for subsequent cutting and coagulation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system generator). It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
963249342
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859729006059FMwand2101FM21012016-06-08
00859729006066FMwand2102FM21022016-06-09
00859729006073FMwand2121FM21212016-06-10
00859729006080FMwand2301FM23012016-06-09
00859729006097FMwand2302FM23022016-06-09
00859729006103FMwand2101SFM2101S2016-06-10
00859729006110FMwand2102SFM2102S2016-06-10
00859729006127FMwand2121SFM2121S2016-06-10
00859729006134FMwand2301SFM2301S2016-06-10
00859729006141FMwand2302SFM2302S2016-06-10
00859729006158FMsealer3001FM30012016-06-15
00859729006165FMsealer4001FM40012016-09-22
00859729006172FMwand2321SFM2321S2016-09-22
00859729006011FMXDPMFMDPM2016-06-08
00859729006028FMXRPMFMRPM2016-06-08
00859729006035FMXG1FPFMG1FP2016-06-08
20859729006053FMwand2101FM21012016-06-08
20859729006060FMwand2102FM21022016-06-09
20859729006077FMwand2121FM21212016-06-10
20859729006084FMwand2301FM23012016-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435288MillenniumAvalign Technologies, Inc.GEI2026-10-19
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B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
00860016247000Super PencilRF KINETICS LLCGEI2026-10-17
00860016247017Super PencilRF KINETICS LLCGEI2026-10-17
00860016247024Super PencilRF KINETICS LLCGEI2026-10-17
00860016247031Super PencilRF KINETICS LLCGEI2026-10-17
00841019124017KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124024KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124048KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124079KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124086KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124093KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124109KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124116KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124123KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124130KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
10381780533276Codman®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEI2026-10-15
10381780533283Codman®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEI2026-10-15
00190776435028MillenniumAvalign Technologies, Inc.GEI2026-10-14
00190776434878MillenniumAvalign Technologies, Inc.GEI2026-10-13
08800142924491OsteoBlate™RF Medical Co.,Ltd.GEI2026-10-13
00190776434656MillenniumAvalign Technologies, Inc.GEI2026-10-12
B108890APMMUS00EMFACE controllerBTL INDUSTRIES LIMITEDGEI2026-10-12
B108890APSMUS00EXION Face applicatorBTL INDUSTRIES LIMITEDGEI2026-10-12