RhinAer Stylus CAT821

GUDID 08886479300184

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 is 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. The RhinAer Stylus treats symptoms of chronic rhinitis by modifying the tissues of the nasal airway through the use of low doses of radiofrequency energy to destroy tissue in the posterior nasal nerve regions. The low-power radiofrequency energy generates heat within the submucosal tissue, destroying local tissue, mucous cells, and glands, and creating a coagulation lesion. This destruction of tissue in posterior nasal nerve regions improves symptoms of chronic rhinitis. The RhinAer Stylus tip is temporarily inserted into the nose to access the treatment area. The procedure requires local anesthesia only.

AERIN MEDICAL INC.

Electrosurgical system
Primary Device ID08886479300184
NIH Device Record Keyaaac3343-a8ad-47b9-b61f-917f9bceb324
Commercial Distribution StatusIn Commercial Distribution
Brand NameRhinAer Stylus
Version Model NumberFG815
Catalog NumberCAT821
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

Phone8334848237
Email[email protected]

Device Identifiers

Device Issuing AgencyDevice ID
GS108886479300184 [Primary]

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 Date2020-02-11
Device Publish Date2020-02-03

Devices Manufactured by AERIN MEDICAL INC.

08886479300184 - RhinAer Stylus2020-02-11The 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 is 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. The RhinAer Stylus treats symptoms of chronic rhinitis by modifying the tissues of the nasal airway through the use of low doses of radiofrequency energy to destroy tissue in the posterior nasal nerve regions. The low-power radiofrequency energy generates heat within the submucosal tissue, destroying local tissue, mucous cells, and glands, and creating a coagulation lesion. This destruction of tissue in posterior nasal nerve regions improves symptoms of chronic rhinitis. The RhinAer Stylus tip is temporarily inserted into the nose to access the treatment area. The procedure requires local anesthesia only.
08886479300184 - RhinAer Stylus2020-02-11 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 is 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. The RhinAer Stylus treats symptoms of chronic rhinitis by modifying the tissues of the nasal airway through the use of low doses of radiofrequency energy to destroy tissue in the posterior nasal nerve regions. The low-power radiofrequency energy generates heat within the submucosal tissue, destroying local tissue, mucous cells, and glands, and creating a coagulation lesion. This destruction of tissue in posterior nasal nerve regions improves symptoms of chronic rhinitis. The RhinAer Stylus tip is temporarily inserted into the nose to access the treatment area. The procedure requires local anesthesia only.
28886479300157 - Sterile Aquasonic 100 Ultrasound Transmission Gel2019-02-18 Sterile Aquasonic 100 Ultrasound Transmission Gel may be used: • On or near broken skin, such as fresh surgical site or open wound where sterility is

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