FlexiWheel

GUDID D77940305014

FlexiWheel Starter Kit

COSMEDENT, INC.

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Primary Device IDD77940305014
NIH Device Record Keye27af333-ad5e-453f-82ad-a4d62224155f
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlexiWheel
Version Model Number403050
Company DUNS113911689
Company NameCOSMEDENT, INC.
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD77940305014 [Primary]

FDA Product Code

EHJDisk, Abrasive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-03
Device Publish Date2020-11-25

On-Brand Devices [FlexiWheel]

D77940305216FlexiWheels Superfine Pink
D77940305115FlexiWheels Medium Blue
D77940305014FlexiWheel Starter Kit

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