Power Cord (OUS) CAT309-01

GUDID 08886479300108

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.

Aerin Medical Inc.

Electrosurgical system
Primary Device ID08886479300108
NIH Device Record Key4b2166c9-2d86-44ff-abf7-34b5e1c91160
Commercial Distribution StatusIn Commercial Distribution
Brand NamePower Cord (OUS)
Version Model NumberMS589
Catalog NumberCAT309-01
Company DUNS051512253
Company NameAerin Medical Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone833-484-8237
Emailcustomerservice@aerinmedical.com
Phone833-484-8237
Emailcustomerservice@aerinmedical.com
Phone833-484-8237
Emailcustomerservice@aerinmedical.com
Phone833-484-8237
Emailcustomerservice@aerinmedical.com
Phone833-484-8237
Emailcustomerservice@aerinmedical.com
Phone833-484-8237
Emailcustomerservice@aerinmedical.com
Phone833-484-8237
Emailcustomerservice@aerinmedical.com
Phone833-484-8237
Emailcustomerservice@aerinmedical.com
Phone833-484-8237
Emailcustomerservice@aerinmedical.com
Phone833-484-8237
Emailcustomerservice@aerinmedical.com
Phone833-484-8237
Emailcustomerservice@aerinmedical.com
Phone833-484-8237
Emailcustomerservice@aerinmedical.com
Phone833-484-8237
Emailcustomerservice@aerinmedical.com
Phone833-484-8237
Emailcustomerservice@aerinmedical.com
Phone833-484-8237
Emailcustomerservice@aerinmedical.com
Phone833-484-8237
Emailcustomerservice@aerinmedical.com
Phone833-484-8237
Emailcustomerservice@aerinmedical.com
Phone833-484-8237
Emailcustomerservice@aerinmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108886479300108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-27
Device Publish Date2023-10-19

Devices Manufactured by Aerin Medical Inc.

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08886479300108 - Power Cord (OUS)2023-10-27The 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.
08886479300108 - Power Cord (OUS)2023-10-27 The power cord is an accessory for the Aerin Console which is an AC (alternating current) radiofrequency generator that incorpor
08886479300122 - Power Cord (UK)2023-10-27 The power cord is an accessory for the Aerin Console which is an AC (alternating current) radiofrequency generator that incorpor
08886479300207 - Power Cord (OUS) 15 FT2023-10-27 The power cord is an accessory for the Aerin Console which is an AC (alternating current) radiofrequency generator that incorpor
08886479300221 - Power Cord (UK) 15 FT2023-10-27 The power cord is an accessory for the Aerin Console which is an AC (alternating current) radiofrequency generator that incorpor
08886479300023 - InSeca ARC Stylus2023-04-04 The InSeca ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. The InSeca
08886479300030 - Aerin Console2023-04-04 The Aerin Console is an AC (alternating current) radiofrequency generator. It incorporates user interface software to control, m

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