VivAer® Stylus CAT723

GUDID 08886479300160

The VivAer® Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. The VivAer® Stylus consists of a handle, shaft and treatment tip. An array of bipolar electrodes is positioned on a nonconductive tip which is attached to a handle via a nonconductive shaft. A temperature sensor is located on the tip to monitor tissue temperature. The Stylus is attached to a Temperature controlled radiofrequency generator (Aerin Console) via a flexible cable.

AERIN MEDICAL INC.

Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system
Primary Device ID08886479300160
NIH Device Record Keyc741d959-b36b-499e-b910-c2e350817434
Commercial Distribution StatusIn Commercial Distribution
Brand NameVivAer® Stylus
Version Model NumberFG722
Catalog NumberCAT723
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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
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
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

Operating and Storage Conditions

Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108886479300160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-27
Device Publish Date2020-10-19

On-Brand Devices [VivAer® Stylus]

08886479300160The VivAer® Stylus is a disposable handheld device capable of delivering bipolar radiofrequency
08886479300269The VivAer® Stylus is a disposable handheld device capable of delivering bipolar radiofrequency

Trademark Results [VivAer]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VIVAER
VIVAER
90703300 not registered Live/Pending
Aerin Medical Inc.
2021-05-11
VIVAER
VIVAER
86457446 4838217 Live/Registered
Aerin Medical Inc.
2014-11-18

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