FlexiDisc Mini 5/8 Coarse

GUDID D7794021581

COSMEDENT, INC.

Dental abrasive disk, single-use Dental abrasive disk, single-use
Primary Device IDD7794021581
NIH Device Record Key58a4bc7f-1c6c-4068-a83d-e63f94016502
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlexiDisc Mini 5/8 Coarse
Version Model Number402158
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
HIBCCD7794021581 [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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D7796722C31 - Bulkfill2022-03-16
D7796722D21 - Bulkfill2022-03-16
D7796722351 - Bulkfill2022-03-09
D7796722A11 - Bulkfill2022-03-09
D7796722A21 - Bulkfill2022-03-09
D7796722A31 - Bulkfill2022-03-09
D7796722B11 - Bulkfill2022-03-09

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