FlexiStrips Narrow Coarse/Medium

GUDID D779501CMN1

COSMEDENT, INC.

Dental abrasive disk, single-use Dental abrasive disk, single-use
Primary Device IDD779501CMN1
NIH Device Record Key79f179c6-63db-4830-bbeb-7d5e870eb7bb
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlexiStrips Narrow Coarse/Medium
Version Model Number501CMN
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 Datetrue
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
HIBCCD779501CMN1 [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.

D7796722B01 - Bulkfill2022-03-16
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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