ASS423-6L

GUDID 08800046041058

GNI Co.,Ltd

Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire
Primary Device ID08800046041058
NIH Device Record Key821d4dec-285b-43df-a0ef-087883e482da
Commercial Distribution StatusIn Commercial Distribution
Brand NameASS423-6L
Version Model NumberASS423-6L
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
GS108800046041058 [Primary]

FDA Product Code

DZCWire, Orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-18
Device Publish Date2023-12-08

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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