FDA.reportPublic FDA data

Edge

Primary DI
00852087007577
Brand
Edge
Company
INFINIUM MEDICAL, INC.
Model
R80
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
00852087007577PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852087007577008520870075778520870075770852087007577

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
00852087007584Edge1602023-06-15
00852087007591Edge2002023-06-15
00852087007607Edge4002023-06-15
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
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00846338001537Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCGEI2026-06-03
00846338001582IEC Power Cord 110vELLIQUENCE, LLCGEI2026-06-03
00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCGEI2026-06-03
00846338001612IEC Power Cord 220v EuropeELLIQUENCE, LLCGEI2026-06-03
00846338001629IEC Power Cord U.K. 220vELLIQUENCE, LLCGEI2026-06-03
00846338006044Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
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00846338006181Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
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00846338006204Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
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00846338006228Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006235Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006242Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006259Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02