Silkn

GUDID 06975782191434

Guangdong Roaman Intelligent Technology Co Ltd

Water jet flosser/sonic electric toothbrush
Primary Device ID06975782191434
NIH Device Record Key512321d9-c5f2-4bf0-afa7-c85ce1a26740
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilkn
Version Model NumberX20B
Company DUNS560456173
Company NameGuangdong Roaman Intelligent Technology Co Ltd
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106975782191434 [Primary]

FDA Product Code

JEQToothbrush, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-02
Device Publish Date2025-05-24

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