VAR-22-553

GUDID 08800046016186

GNI Co.,Ltd

Self-ligating orthodontic bracket Self-ligating orthodontic bracket Self-ligating orthodontic bracket Self-ligating orthodontic bracket Self-ligating orthodontic bracket Self-ligating orthodontic bracket Self-ligating orthodontic bracket Self-ligating orthodontic bracket Self-ligating orthodontic bracket Self-ligating orthodontic bracket Self-ligating orthodontic bracket Self-ligating orthodontic bracket
Primary Device ID08800046016186
NIH Device Record Keydf865529-3ba7-4ef6-8992-7e5505197af1
Commercial Distribution StatusIn Commercial Distribution
Brand NameVAR-22-553
Version Model NumberVAR-22-553
Company DUNS694828541
Company NameGNI Co.,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 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
GS108800046016186 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NJMBracket, Ceramic, Orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-14
Device Publish Date2022-12-06

Devices Manufactured by GNI Co.,Ltd

08800046000642 - SA1208C2024-01-03
08800046000659 - SA1210C2024-01-03
08800046000666 - SA1406C2024-01-03
08800046000673 - SA1408C2024-01-03
08800046000680 - SA1410C2024-01-03
08800046000697 - SA1606C2024-01-03
08800046000703 - SA1608C2024-01-03
08800046000710 - SA1610C2024-01-03
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