FDA.reportPublic FDA data

Power Cord (UK)

Primary DI
08886479300122
Brand
Power Cord (UK)
Company
Aerin Medical Inc.
Model
MS588
Catalog number
CAT309-03
Device description
The power cord is an accessory for the Aerin Console which is an AC (alternating current) radiofrequency generator that incorporates user interface software to control, monitor and regulate RF power delivery to soft tissues via a cable-connected electrosurgical hand piece and electrode.
Published
2023-10-19
Public version status
New
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
K162810000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162810000InSeca ARC Stylus, Aerin ConsoleAerin Medical, Inc.2017-01-11GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08886479300122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08886479300122088864793001228886479300122

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

Contacts#

Phone, Email table
PhoneEmail
833-484-8237customerservice@aerinmedical.com

Regulatory Flags#

DUNS number
051512253
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08886479300306RhinAer+ StylusFG2258CAT22592025-09-19
08886479300023InSeca ARC StylusFG256CAT4092017-12-19
08886479300146Vivaer ARC StylusFG257CAT4102017-12-19
08886479300160VivAer® StylusFG722CAT7232020-10-19
08886479300184RhinAer StylusFG815CAT8212020-02-03
08886479300269VivAer® StylusFG1787CAT17852024-01-05
08886479300030Aerin ConsoleFG226CAT3052017-12-19
08886479300238RhinAer® StylusFG1393CAT13942022-08-19
08886479300047Aerin Console SetCAT305CAT305-022017-12-19
08886479300283Aerin ConsoleFG2045CAT20462024-12-18
08886479300290Aerin Console SetFG2045CAT2046-012024-12-18
08886479300252Reach NeedleCAT1614-05CAT1614-052024-06-10
28886479300256Reach NeedleCAT1614-05CAT1614-052024-06-10
08886479300108Power Cord (OUS)MS589CAT309-012023-10-19
08886479300207Power Cord (OUS) 15 FTMS1222CAT309-042023-10-19
08886479300221Power Cord (UK) 15 FTMS1223CAT309-062023-10-19
08886479300115Power CordCAT309-02CAT309-022017-12-19
08886479300139Foot SwitchCAT307CAT3072017-12-19
08886479300214Power Cord 15 ft (US)MS1198309-052021-07-15
28886479300157Sterile Aquasonic 100 Ultrasound Transmission GelMS303CAT447-Q062017-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091292ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
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00198506091377ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091384ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091391ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00860015792006NOVOCLEAR™ DeviceAventix Medical Inc.GEI2026-06-09
00860015792013AVENTIX® PFX SystemAventix Medical Inc.GEI2026-06-09
00685447020677RFP-100A™ RF Puncture GeneratorBOSTON SCIENTIFIC CORPORATIONGEI2026-06-08
08800042706159Artisential Monopolar SpatulaLIVSMEDGEI2026-06-05
00840319759042Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759059Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759066Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759073Hayden MedicalHayden Medical, Inc.GEI2026-06-04
08809306764072VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764089VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764133VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764140VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764157VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764164VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764171VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764188VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
00198506091261ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-03
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00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCGEI2026-06-03
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