FlexiStrips Regular Coarse/Medium

GUDID D779501SMR1

COSMEDENT, INC.

Dental abrasive disk, single-use Dental abrasive disk, single-use
Primary Device IDD779501SMR1
NIH Device Record Key84fbe3c0-cf61-41e1-a71f-9b05d339c133
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlexiStrips Regular Coarse/Medium
Version Model Number501CMR
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
HIBCCD779501SMR1 [Primary]

FDA Product Code

EHMStrip, Polishing Agent

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 Date2020-02-10

Devices Manufactured by COSMEDENT, INC.

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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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