NOVA-S SAPPHIRE BRACKET 466-234

GUDID D9094662330

.022 UBICL NOVA-S SAPPHIRE BRACKET - MBT (5)

Ortho Arch Company Inc

Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic
Primary Device IDD9094662330
NIH Device Record Key7194ed4e-abc7-4326-9462-8ec90f4bf8c5
Commercial Distribution StatusIn Commercial Distribution
Brand NameNOVA-S SAPPHIRE BRACKET
Version Model Number.022 UBICL - MBT
Catalog Number466-234
Company DUNS020956330
Company NameOrtho Arch Company Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD9094662330 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NJMBracket, Ceramic, Orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-08
Device Publish Date2022-05-31

On-Brand Devices [NOVA-S SAPPHIRE BRACKET]

D9094662330.022 UBICL NOVA-S SAPPHIRE BRACKET - MBT (5)
D9094664720.022 L5L NOVA-S SAPPHIRE BRACKET -22T HOOK (5)
D9094664620.022 L4L NOVA-S SAPPHIRE BRACKET -17T HOOK (5)
D9094664510.022 L3R NOVA-S SAPPHIRE BRACKET - HK ROTH (5)

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