Temporary Cement Remover 1005168

GUDID H65810038361

Temporary Cement Ultrasonic Cleaning Solution

HENRY SCHEIN, INC.

Medical device cleaning agent
Primary Device IDH65810038361
NIH Device Record Key70c3e259-ffe2-40c0-807e-be576a69e1b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameTemporary Cement Remover
Version Model Number1005168
Catalog Number1005168
Company DUNS012430880
Company NameHENRY SCHEIN, 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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100304040028926 [Primary]
HIBCCH65810038361 [Secondary]

FDA Product Code

FLGCleaner, ultrasonic, medical instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-27
Device Publish Date2024-02-19

Devices Manufactured by HENRY SCHEIN, INC.

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00304040187517 - Zirlux2026-02-12 ZIRLUX ML DISC B1 98x14 Ea
00304040187524 - Zirlux2026-02-12 ZIRLUX ML DISC B2 98x14 Ea
00304040187531 - Zirlux2026-02-12 ZIRLUX ML DISC B3 98x14 Ea
00304040187548 - Zirlux2026-02-12 ZIRLUX ML DISC B4 98x14 Ea
00304040187555 - Zirlux2026-02-12 ZIRLUX ML DISC C1 98x14 Ea

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