SBN-E18-1M41G

GUDID 08800046039208

GNI Co.,Ltd

Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube
Primary Device ID08800046039208
NIH Device Record Key43e1d983-1d01-48f9-bd7d-b3343ced011e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSBN-E18-1M41G
Version Model NumberSBN-E18-1M41G
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
GS108800046039208 [Primary]

FDA Product Code

DZDTube, Orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-19
Device Publish Date2023-10-11

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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