NOVA-S SAPPHIRE 466-063

GUDID D9094660630

.018 LBIC NOVA-S SAPPHIRE BRACKET -12T (5)

Ortho Arch Company Inc

Orthodontic bracket, ceramic
Primary Device IDD9094660630
NIH Device Record Key8d068acf-fdae-41cc-ba00-9aa6cb0b2642
Commercial Distribution StatusIn Commercial Distribution
Brand NameNOVA-S SAPPHIRE
Version Model Number.018 LBIC
Catalog Number466-063
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
HIBCCD9094660630 [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 Date2022-05-11
Device Publish Date2022-05-03

On-Brand Devices [NOVA-S SAPPHIRE]

D90946601104.018 U2R NOVA-S SAPPHIRE BRACKET - MBT (5)
D90946600204.018 U1L NOVA-S SAPPHIRE BRACKET - MBT (5)
D90946600103.018 U1R NOVA-S SAPPHIRE BRACKET - MBT (5)
D9094660730.018 LBIC NOVA-S SAPPHIRE BRACKET -17T (5)
D9094660720.018 L5L NOVA-S SAPPHIRE BRACKET -17T HOOK (5)
D9094660710.018 L5R NOVA-S SAPPHIRE BRACKET -17T HOOK (5)
D9094660630.018 LBIC NOVA-S SAPPHIRE BRACKET -12T (5)
D9094660620.018 L4L NOVA-S SAPPHIRE BRACKET -12T HOOK (5)
D90946606109.018 L4R NOVA-S SAPPHIRE BRACKET -12T HOOK (5)
D90946605209.018 L3L NOVA-S SAPPHIRE BRACKET - HK MBT (5)
D90946605108.018 L3R NOVA-S SAPPHIRE BRACKET - HK MBT (5)
D9094660450.018 LA NOVA-S SAPPHIRE BRACKET - MBT (5)
D90946603308.018 UBIC NOVA-S SAPPHIRE BRACKET - MBT (5)
D90946603207.018 UBICL NOVA-S SAPPHIRE BRACKET - HK MBT (5)
D90946603106.018 UBICR NOVA-S SAPPHIRE BRACKET - HK MBT (5)
D90946602206.018 U3L NOVA-S SAPPHIRE BRACKET - HK MBT (5)
D90946601205.018 U2L NOVA-S SAPPHIRE BRACKET - MBT (5)
D90946602105.018 U3R NOVA-S SAPPHIRE BRACKET - HK MBT (5)

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