FDA.reportPublic FDA data

HelixAR

Primary DI
30653405005531
Brand
HelixAR
Company
Conmed Corporation
Model
60-8800-001
Catalog number
60-8800-001
Device description
HelixAR 100 - 240 VAC 50/60 Hz Electrosurgical Unit with Argon Beam Coagulator
Published
2018-03-20
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172671000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172671000HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile PedestalConmed Corporation2017-10-04GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20653405005534Direct MarkingGS10
30653405005531PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2065340500553420653405005534
3065340500553130653405005531

GMDN Terms#

Term, Definition table
TermDefinition
Inert gas-enhanced electrosurgical systemAn assembly of devices that uses radio-frequency (RF) alternating current to develop heat directly within soft-tissue cells (thermodynamic) for cutting and coagulating tissue within a shield of an inert gas [e.g., argon (Ar), helium (He)] during surgery. It typically includes a generator, a single-use/reusable electrode handpiece with monopolar electrodes, connecting cables, foot-switch, and a gas supply system [housed in a separate trolley (cart) or incorporated into the system generator]. The current forms an ionized channel or arc within the gas shield which lessens the charring of tissue and provides rapid, uniform coagulation over large bleeding surfaces (e.g., capillary beds).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius32 Degrees Celsius
Storage Environment Temperature50 Degrees Fahrenheit89.6 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
071595540
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10845854051399AirSealiAS8-dViAS8-dV2021-08-22
10845854084137AirSeal®iAS8-dVLiAS8-dVL2023-01-06
10845854013137QUICKLATCHQL4300QL43002020-12-10
10845854031841CONMEDT2531T25312020-12-10
10845854036204POWERPROPRO6185PRO61852023-09-01
20845854061807SnapEvacSNAPEVAC20SNAPEVAC202020-06-06
30653405011907EXCEL60-6050-00160-6050-0012016-09-24
30653405988346Argo KnotlessK55RTAPK55RTAP2023-01-13
30653405988360Argo KnotlessK475RTAPK475RTAP2023-01-13
10845854032619CROSSFTTFT-45MTFT-45M2021-01-19
10845854032633CROSSFTTFT-55MTFT-55M2021-01-19
10845854032657CROSSFTTFT-65MTFT-65M2021-01-19
10653405004646ELECTROLASE HYFRECATOR7-100-8BX7-100-8BX2016-09-24
10653405013785THERMOGARD7-3847-3842016-09-24
10845854650134THERMOGARD7-3827-3822022-09-21
20653405051906Precisor0008520008522016-09-24
20653405051920Precisor0008540008542016-09-24
30653405046800BiCap SuperconductorBP-10300ABP-10300A2016-09-24
30653405046992BiCap SuperconductorBP-7300ABP-7300A2016-09-24
30653405047005BiCap SuperconductorBP-5200ABP-5200A2016-09-24

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