FDA.reportPublic FDA data

Edge

Primary DI
00852087007607
Brand
Edge
Company
INFINIUM MEDICAL, INC.
Model
400
Published
2023-06-15
Public version status
New
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
K220138000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220138000Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HPLed Spa2022-10-05GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852087007607PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852087007607008520870076078520870076070852087007607

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical systemAn assembly of devices intended to generate, and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation 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). The assembly includes a mains electricity-powered (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and electrodes to apply the energy to the surgical site. Tissue resistance to the electrical current creates the heat as the current travels through the body between electrodes; it is not intended for inert gas-enhanced electrosurgery.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
037504771
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852087007881Infinium Medical Inc.OBA Anesthesia Machine2024-05-06
00852087007898Infinium Medical Inc.OBA MRI Compatible Anesthesia Machine2024-05-06
00852087007577EdgeR802023-06-15
00852087007584Edge1602023-06-15
00852087007591Edge2002023-06-15
00852087007522Infinium MedicalOMNI II K2021-12-10
00852087007034Infinium MedicalOMNI III2017-03-06
00852087007003Infinium MedicalOMNI K2017-03-06
00852087007010Infinium MedicalOMNI Express2017-03-06
00852087007027Infinium MedicalOMNI II2017-03-06
00852087007041Infinium MedicalCLEO2017-03-06
00852087007058Infinium MedicalOMNI2017-03-06
00852087007065AxiaTRIA2017-03-06
00852087007072AxiaV1050T2017-03-06
00852087007089AxiaV1200T2017-03-06
00852087007096AxiaV1500A2017-03-06
00852087007102Schiller AmericasT Lite2017-03-06
00852087007119Schiller AmericasTranquility II2017-03-06
00852087007171Schiller AmericasTranquility VS2017-03-06
00820870070345Infinium MedicalOMNI III2017-03-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776398484MillenniumAvalign Technologies, Inc.GEI2026-07-16
08800020100276INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100283INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100306INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100313INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100320INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100337INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020104984DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020104991DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105004DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105059DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105066DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105073DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020106827DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020107626DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020107633DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110565INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110572INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110640FootswitchJeisys Medical Inc.GEI2026-07-16
B382SD08890310101D0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD08890320101D0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD7720520001Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD7720585030Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD84032220032B0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD8406210032B0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89029200Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89039060Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89139290Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD8917450Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89179290Surgical DirectSurgical Direct, Inc.GEI2026-07-14