Home GUDID 07290112451675 Silk'n
Primary DI 07290112451675
Brand Silk'n
Company HOME SKINOVATIONS LTD
Model ToothWave US
Catalog number 7290112451675
Device description ToothWave™ is a powered radiofrequency toothbrush intended to promote good oral hygiene, including reduction of plaque and the prevention and treatment of gingivitis. ToothWave™ is intended for over-the-counter use.
Published 2021-05-19
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile false
Single use false Product Codes# Code, Name table Code Name QMJ Powered Radiofrequency Toothbrush
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QMJ Powered Radiofrequency Toothbrush Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07290112451675 Direct Marking GS1 0 27290112451679 Package GS1 6 In Commercial Distribution 17290112451672 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07290112451675 07290112451675 7290112451675 27290112451679 27290112451679 17290112451672 17290112451672
GMDN Terms# Term, Definition table Term Definition Radio-frequency toothbrush An electrically-powered toothbrush, that additionally applies to dentition a radio-frequency (RF) alternating current, designed to be used to brush clean teeth and gums (i.e., remove plaque, tartar, stains). It consists of a proximal handle, and an exchangeable distal head with rows of bristles (e.g., nylon) and electrodes to generate the RF current into toothpaste and along dentition. This is a reusable device.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Handling Environment Humidity 15 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Handling Environment Temperature 5 Degrees Celsius 40 Degrees Celsius Storage Environment Atmospheric Pressure 50 KiloPascal 106 KiloPascal Storage Environment Humidity 10 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Storage Environment Temperature -40 Degrees Celsius 70 Degrees Celsius
Regulatory Flags# DUNS number 514891048 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false 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# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 17290112451672 Silk'n HOME SKINOVATIONS LTD QMJ 2021-05-19
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