RhinAer+ Stylus CAT2259

GUDID 08886479300306

The RhinAer+ Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. The RhinAer+ Stylus consists of a handle, shaft, and treatment tip. An array of bipolar electrodes are positioned on a non-conductive tip which is attached to a handle via a non-conductive shaft. A temperature sensor is located on the tip to monitor tissue temperature. The Stylus is attached to a temperature-controlled radiofrequency generator via a flexible cable.

Aerin Medical Inc.

Electrosurgical system
Primary Device ID08886479300306
NIH Device Record Key8128e599-641b-463d-a916-adfb05854c70
Commercial Distribution StatusIn Commercial Distribution
Brand NameRhinAer+ Stylus
Version Model NumberFG2258
Catalog NumberCAT2259
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS108886479300306 [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 Date2025-09-29
Device Publish Date2025-09-19

Devices Manufactured by Aerin Medical Inc.

08886479300306 - RhinAer+ Stylus2025-09-29The RhinAer+ Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. The RhinAer+ Stylus consists of a handle, shaft, and treatment tip. An array of bipolar electrodes are positioned on a non-conductive tip which is attached to a handle via a non-conductive shaft. A temperature sensor is located on the tip to monitor tissue temperature. The Stylus is attached to a temperature-controlled radiofrequency generator via a flexible cable.
08886479300306 - RhinAer+ Stylus2025-09-29 The RhinAer+ Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. The RhinAer+
08886479300283 - Aerin Console2024-12-26 The Aerin Console is an AC (alternating current) radiofrequency generator. It incorporates user interface software to control, m
08886479300290 - Aerin Console Set2024-12-26 The Aerin Console is an AC (alternating current) radiofrequency generator. It incorporates user interface software to control, m
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
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