SSBC-M22-464G

GUDID 08800046051309

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 ID08800046051309
NIH Device Record Keya16da0f8-1960-42f9-b8f2-2eccf5929c4e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSSBC-M22-464G
Version Model NumberSSBC-M22-464G
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
GS108800046051309 [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 Date2024-06-26
Device Publish Date2024-06-18

Devices Manufactured by GNI Co.,Ltd

08800046051309 - SSBC-M22-464G2024-06-26
08800046051309 - SSBC-M22-464G2024-06-26
08800046051316 - SSBC-M22-364G2024-06-26
08800046051323 - SSBC-M22-264G2024-06-26
08800046051330 - SSBC-M22-164G2024-06-26
08800046051385 - SSBC-M22-1M44G2024-06-26
08800046027540 - IES1-10012024-06-12
08800046045896 - P01-012024-06-12
08800046046602 - SN02-10182024-06-12

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