OrthoStore - MINT 625-300

GUDID 00843471100035

MINT

YOUNG INNOVATIONS HOLDINGS LLC

Alginate dental impression material
Primary Device ID00843471100035
NIH Device Record Keye43d1324-f998-461e-aebc-da641b9a24a1
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrthoStore - MINT
Version Model Number625-300
Catalog Number625-300
Company DUNS078739060
Company NameYOUNG INNOVATIONS HOLDINGS LLC
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 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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 2.7 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 2.7 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 2.7 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 2.7 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 2.7 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 2.7 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 2.7 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 2.7 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 2.7 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 2.7 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 2.7 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 2.7 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100843471100035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELWMaterial, Impression

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 Date2018-02-19

Devices Manufactured by YOUNG INNOVATIONS HOLDINGS LLC

00843471100097 - Plak Smacker2020-05-06 Trufit Blue Facemask (50/bx)
00843471100004 - OrthoStore - BUBBLEGUM 2018-07-06 BUBBLEGUM
00843471100011 - OrthoStore - COTTON CANDY 2018-07-06 COTTON CANDY
00843471100028 - OrthoStore - STRAWBERRY 2018-07-06 STRAWBERRY FLAVORING
00843471100035 - OrthoStore - MINT 2018-07-06MINT
00843471100035 - OrthoStore - MINT 2018-07-06 MINT
00843471100042 - OrthoStore - GRAPE2018-07-06 GRAPE
00843471100059 - OrthoStore - ROOTBEER 2018-07-06 ROOTBEER
00843471100066 - OrthoStore - CHERRY 2018-07-06 CHERRY

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