Foot Switch CAT307

GUDID 08886479300139

The foot switch is an accessory for use with 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 ID08886479300139
NIH Device Record Key86abce9c-ce79-45e3-bce6-c1a5ffc4435f
Commercial Distribution StatusIn Commercial Distribution
Brand NameFoot Switch
Version Model NumberCAT307
Catalog NumberCAT307
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

Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108886479300139 [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 StatusUpdate
Device Record StatusPublished
Public Version Number7
Public Version Date2023-04-04
Device Publish Date2017-12-19

Devices Manufactured by AERIN MEDICAL INC.

28886479300256 - Reach Needle2024-06-18 Single use anesthesia needle
08886479300269 - VivAer® Stylus2024-01-15 The VivAer® Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. The VivAer®
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.