EasySoft Liner Laboratory Package

GUDID 00627843583776

4 x 50 ml EasySoft liner 2 x 10 ml EasySoft liner adhesive (28 mixing tips that are only used outside of the mouth and are not medical devices)

Karlin Dental Distributors Inc

Denture reliner, soft, professional
Primary Device ID00627843583776
NIH Device Record Keyfb26fe35-40fd-47d3-bd09-59c39e9ab717
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasySoft Liner Laboratory Package
Version Model Number0502
Company DUNS243750762
Company NameKarlin Dental Distributors Inc
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-519-720-9424
Emailbiggrin@rogers.com
Phone1-519-720-9424
Emailbiggrin@rogers.com

Device Dimensions

Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 16 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100627843583776 [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 Number2
Public Version Date2018-03-29
Device Publish Date2016-09-08

Devices Manufactured by Karlin Dental Distributors Inc

00627843583752 - EasySoft Liner Adhesive2018-03-29
00627843583769 - EasySoft Liner Starter Kit2018-03-29 2 x 50 ml EasySoft Liner 1 x 50 ml EasySoft Liner Sealant 1 x 10 ml EasySoft Liner Adhesive (mixing tips, brushes, polishing dis
00627843583776 - EasySoft Liner Laboratory Package2018-03-294 x 50 ml EasySoft liner 2 x 10 ml EasySoft liner adhesive (28 mixing tips that are only used outside of the mouth and are not medical devices)
00627843583776 - EasySoft Liner Laboratory Package2018-03-29 4 x 50 ml EasySoft liner 2 x 10 ml EasySoft liner adhesive (28 mixing tips that are only used outside of the mouth and are not m
00627843583783 - EasySoft Liner Sealant2018-03-29
00627843583790 - EasySoft Liner Twin Refill Package2018-03-29 2 x 50 ml EasySoft Liner cartridges

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