FlexiDisc Regular 5/8 Coarse Sand

GUDID D7794015581

COSMEDENT, INC.

Dental abrasive disk, single-use Dental abrasive disk, single-use
Primary Device IDD7794015581
NIH Device Record Key4ae59b4c-0a31-4687-944c-f2c386d984fc
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlexiDisc Regular 5/8 Coarse Sand
Version Model Number401558
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 Usetrue
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
HIBCCD7794015581 [Primary]

FDA Product Code

EHJDisk, Abrasive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-05-06
Device Publish Date2020-01-22

Devices Manufactured by COSMEDENT, INC.

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D7796722A21 - Bulkfill2022-03-09
D7796722A31 - Bulkfill2022-03-09
D7796722B11 - Bulkfill2022-03-09

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