NuSmile NeoLINER LC Sample Pack (1 g Syringe + 5 Tips, No IFU)

GUDID 00810118103995

NuSmile NeoLINER LC Sample Pack (1 g Syringe + 5 Tips, No IFU)

NUSMILE, LTD.

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Primary Device ID00810118103995
NIH Device Record Key6d5cee18-dc4b-4296-8f6c-cf70dee56efe
Commercial Distribution StatusIn Commercial Distribution
Brand NameNuSmile NeoLINER LC Sample Pack (1 g Syringe + 5 Tips, No IFU)
Version Model NumberNNLSP
Company DUNS185497372
Company NameNUSMILE, LTD.
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810118103995 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EJKLiner, Cavity, Calcium Hydroxide

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-08
Device Publish Date2023-11-30

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