Bosworth Copaliner 0921526

GUDID H66809215261

Cavity Varnish

Harry J Bosworth Company

Dental cavity varnish
Primary Device IDH66809215261
NIH Device Record Key845b79f9-671c-450f-ba6d-e4bb3bdca62f
Commercial Distribution StatusIn Commercial Distribution
Brand NameBosworth Copaliner
Version Model Number0921526
Catalog Number0921526
Company DUNS014769301
Company NameHarry J Bosworth Company
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)333-3131
Emailtschwear@keystoneind.com

Device Dimensions

Total Volume14 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCH66809215261 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LBHVARNISH, CAVITY

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-15

On-Brand Devices [Bosworth Copaliner]

H66809215271Copaliner Solvent
H66809215261Cavity Varnish
H66809215251Cavity Varnish & Sealant Kit

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