Home GUDID 86573000021011
VeinGogh
Primary DI 86573000021011
Brand VeinGogh
Company AP MEDESTHETICS, INC.
Model 101
Device description VeinGogh electrocoagulation for aesthetic applies RF energy for treatment of lower limb spider vein or Telangiectasias. The device is aproved for use
Published 2016-12-22
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name ONQ Electrosurgical Coagulation For Aesthetic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ONQ Electrosurgical Coagulation For Aesthetic General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 86573000021011 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 86573000021011 86573000021011
GMDN Terms# Term, Definition table Term Definition Radio-frequency ablation system generator A mains electricity (AC-powered) device designed to generate radio-frequency (RF) electrical current used to create heat via an electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues, including nerves, tumours, precancerous tissue; it may be intended for coagulation however it is not intended for electrosurgical cutting. The generator connects via a delivery cable to an electrosurgical ablation probe/catheter (not included) to transmit the RF energy to the operative site.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Humidity 20 Percent (%) Relative Humidity 80 Percent (%) Relative Humidity Handling Environment Temperature 10 Degrees Celsius 32 Degrees Celsius Storage Environment Humidity 20 Percent (%) Relative Humidity 80 Percent (%) Relative Humidity Storage Environment Temperature 1 Degrees Celsius 40 Degrees Celsius
Regulatory Flags# DUNS number 056296605 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes#