Countertop Water Dental Flosser

GUDID 00681131116091

Battery powered flosser

Gurunanda, LLC

Oral lavage system Oral lavage system Oral lavage system Oral lavage system Oral lavage system Oral lavage system Oral lavage system Oral lavage system Oral lavage system Oral lavage system Oral lavage system Oral lavage system Oral lavage system Oral lavage system Oral lavage system Oral lavage system Oral lavage system Oral lavage system
Primary Device ID00681131116091
NIH Device Record Keyf8038c2f-13b7-44a9-a390-bff016f21021
Commercial Distribution StatusIn Commercial Distribution
Brand NameCountertop Water Dental Flosser
Version Model NumberFC162
Company DUNS079671169
Company NameGurunanda, LLC
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-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100681131116091 [Primary]

FDA Product Code

EFSUnit, Oral Irrigation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-31
Device Publish Date2023-03-23

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