IES1-1001

GUDID 08800046027540

GNI Co.,Ltd

Orthodontic retainer
Primary Device ID08800046027540
NIH Device Record Key809f4c8e-213f-48b2-ab68-7813ecb21ee2
Commercial Distribution StatusIn Commercial Distribution
Brand NameIES1-1001
Version Model NumberIES1-1001
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
GS108800046027540 [Primary]

FDA Product Code

DYJRetainer, Screw Expansion, Orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-12
Device Publish Date2024-06-04

Devices Manufactured by GNI Co.,Ltd

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
08800046027540 - IES1-10012024-06-12
08800046045896 - P01-012024-06-12
08800046046602 - SN02-10182024-06-12

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