AccessGUDID - DEVICE: Silk'n (17290112451672)

GUDID

Device Identifier (DI) Information

Brand Name: Silk'n
Version or Model: ToothWave US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7290112451675
Company Name: HOME SKINOVATIONS LTD

Primary DI Number: 17290112451672
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 514891048 *Terms of Use

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.

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
65482	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QMJ	Powered Radiofrequency Toothbrush

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN190039	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 5 and 40 Degrees Celsius
Handling Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 70 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 222f7018-2561-4033-b14a-ccddabb64f1f
Public Version Date: May 27, 2021
Public Version Number: 1
DI Record Publish Date: May 19, 2021