Bosworth Light Liner 0921463

GUDID H66809214631

Hard P&L Standard Kit

Harry J Bosworth Company

Denture reliner, hard
Primary Device IDH66809214631
NIH Device Record Key39f2c88c-2f5f-42d6-b26d-7657102b6eb5
Commercial Distribution StatusIn Commercial Distribution
Brand NameBosworth Light Liner
Version Model Number0921463
Catalog Number0921463
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 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
HIBCCH66809214631 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Number4
Public Version Date2018-08-09
Device Publish Date2016-09-15

On-Brand Devices [Bosworth Light Liner]

H6680921499S1Soft Reline Mat. P&L Single Dose
H66809214991Hard Reline Mat. P&L Single Dose
H66809214641Soft Reline P&L Standard Kit
H66809214631Hard P&L Standard Kit

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