Ou Nuo

GUDID 06975683900289

Changzhou Ou Nuo Medical Equipment Co., Ltd.

Dental appliance fabrication material, thermoplastic
Primary Device ID06975683900289
NIH Device Record Key68bf21bd-76a4-4d34-9cee-d3895a5b687d
Commercial Distribution StatusIn Commercial Distribution
Brand NameOu Nuo
Version Model NumberT088
Company DUNS723688236
Company NameChangzhou Ou Nuo Medical Equipment Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106975683900289 [Primary]

FDA Product Code

EBHMaterial, Impression Tray, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-23
Device Publish Date2024-08-15

On-Brand Devices [Ou Nuo]

06975683900012T040RC125N
06975683900067T100RC125N
06975683900050T088RC125N
06975683900043T076RC125N
06975683900036T063RC125N
06975683900029T050RC125N
06975683900098P040
06975683900296T100
06975683900289T088
06975683900272T076
06975683900265T063
06975683900258T050
06975683900241T040
06975683900234C200
06975683900227C150
06975683900210C100
06975683900203C088
06975683900197C076
06975683900180C063
06975683900173C050
06975683900166P200
06975683900159P150
06975683900142P100
06975683900135P088
06975683900128P076
06975683900111P063
06975683900104P050
06975683900074T076MC125N

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