AccessGUDID - DEVICE: VivAer® Stylus (08886479300269)

GUDID

Device Identifier (DI) Information

Brand Name: VivAer® Stylus
Version or Model: FG1787
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CAT1785
Company Name: Aerin Medical Inc.

Primary DI Number: 08886479300269
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 051512253 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44776	Electrosurgical system	An assembly of devices intended to generate, and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system). The assembly includes a mains electricity-powered (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and electrodes to apply the energy to the surgical site. Tissue resistance to the electrical current creates the heat as the current travels through the body between electrodes; it is not intended for inert gas-enhanced electrosurgery.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K200300	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Humidity: between 20 and 85 Percent (%) Relative Humidity
Handling Environment Temperature: between 5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 83ec2a27-a23f-405e-9fd4-06dc1722e801
Public Version Date: January 15, 2024
Public Version Number: 1
DI Record Publish Date: January 05, 2024