Bosworth Original Truliner 0921940

GUDID H66809219401

Orig Truliner PMMA Standard P&L Kit Pink

Harry J Bosworth Company

Denture reliner, hard
Primary Device IDH66809219401
NIH Device Record Key283cab19-d69d-449d-99db-54bc8c893471
Commercial Distribution StatusIn Commercial Distribution
Brand NameBosworth Original Truliner
Version Model Number0921940
Catalog Number0921940
Company DUNS014769301
Company NameHarry J Bosworth Company
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCH66809219401 [Primary]

FDA Product Code

EBIRESIN, DENTURE, RELINING, REPAIRING, REBASING

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-08-09
Device Publish Date2016-09-15

On-Brand Devices [Bosworth Original Truliner]

H66809219601Qt Orig Truliner Liquid
H668092195915 lb Orig Truliner PMMA Pwd Clear
H668092195815 lb Orig Truliner PMMA Pwd Vein
H668092195715 lb Orig Truliner PMMA Pwd Pink
H668092195211 lb bulk Orig Truliner PMMA P&L Kit Vein
H668092195111 lb bulk Orig Truliner PMMA P&L Kit Pink
H66809219501Orig Truliner Liquid
H66809219481Orig Truliner PMMA Pwd Vein
H66809219471Orig Truliner PMMA Pwd Pink
H66809219461Orig Truliner Liquid
H66809219451Orig Truliner PMMA Pwd Clear
H66809219441Orig Truliner PMMA Pwd Vein
H66809219431Orig Truliner PMMA Pwd Pink
H66809219421Orig Truliner PMMA Standard P&L Kit Clear
H66809219411Orig Truliner PMMA Standard P&L Kit Vein
H66809219401Orig Truliner PMMA Standard P&L Kit Pink

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