NeoLINER LC 1 g Kit

GUDID 00810092939276

NeoLINER LC 1 g Kit - 1 g + 15 Tips

NUSMILE, LTD.

Dental composite resin
Primary Device ID00810092939276
NIH Device Record Key3685bf93-2f66-49f3-9f25-ed02b83e0a65
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeoLINER LC 1 g Kit
Version Model NumberNNLSK
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
GS100810092939276 [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 Date2022-07-26
Device Publish Date2022-07-18

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