FDA.reportPublic FDA data

ArConnect

Primary DI
10724995180284
Brand
ArConnect
Company
US Endoscopy
Model
G1120020
Catalog number
G1120020
Device description
The ArConnect argon probe connector allows the delivery of monopolar high frequency electrosurgical energy and argon gas to a single use argon coagulation probe (not included) and is for the exclusive use with the gi4000 Electrosurgical Unit.
Published
2022-02-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
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
K192265000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192265000gi-4000 Electrosurgical GeneratorUnited States Endoscopy Group, Inc.2020-05-21GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10724995180284PackageGS110In Commercial Distribution
00724995180287PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499518028410724995180284
00724995180287007249951802877249951802870724995180287

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical return electrode, single-useA dispersive conductor intended to be fastened to a patient and connected to an electrosurgical/radio-frequency ablation system generator, to allow return of electrical current from the patient to the generator during an electrosurgical procedure. It has a large surface area and is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It will typically be designed with permanently attached leads. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
627879687
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995182557Exacto00711094007110942021-03-31
00724995182564Exacto00711095007110952021-03-31
00724995182618Exacto00711115007111152021-03-31
00724995243746Exacto Mundo00711114007111142025-01-31
00724995180959VIA00717001007170012020-01-31
00724995181116VIA00717019007170192020-01-30
00724995181420VIA00717051007170512020-01-30
00724995181451VIA00717054007170542020-01-30
00724995181505VIA00717059007170592020-01-30
00724995181659VIA00717076007170762020-01-30
00724995182984VIA00717141007171412020-01-30
00724995183073VIA00717155007171552020-07-16
00724995183141VIA00717167007171672020-01-30
00724995183257VIA00717182007171822020-01-30
00724995190699VIA00717223007172232020-01-30
00724995190736VIA00717234007172342020-01-30
00724995193966VIA00717269007172692020-02-04
00724995194123VIA00717229007172292020-02-07
00724995194987VIA00717310007173102020-03-23
00724995203412VIA00717337007173372020-10-20

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00198506092923ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
B382SD89239290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89509290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89529290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89759150Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89819320Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839280Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89914450Surgical DirectSurgical Direct, Inc.GEI2026-07-17
00190776398484MillenniumAvalign Technologies, Inc.GEI2026-07-16
08800020100276INTRAcel TipJeisys Medical Inc.GEI2026-07-16
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08800020110565INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110572INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
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