Nyclave TTS Autoclave Indicator Labels

GUDID 10302731112128

YOUNG DENTAL MANUFACTURING I, LLC

Chemical/physical sterilization process indicator
Primary Device ID10302731112128
NIH Device Record Keye98a85ae-72d1-4a30-8d0d-a85c7e60b29c
Commercial Distribution StatusIn Commercial Distribution
Brand NameNyclave TTS Autoclave Indicator Labels
Version Model Number111212
Company DUNS006309355
Company NameYOUNG DENTAL MANUFACTURING I, 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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110302731112128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOJIndicator, Physical/Chemical Sterilization Process

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-02-19
Device Publish Date2016-09-23

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