NOVA -S SAPPHIRE BRACKET 466-445

GUDID D9094664450

.022 LA NOVA -S SAPPHIRE BRACKET - ROTH (5)

Ortho Arch Company Inc

Orthodontic bracket, ceramic
Primary Device IDD9094664450
NIH Device Record Key09433545-fba2-4bfb-af27-a1948da7d132
Commercial Distribution StatusIn Commercial Distribution
Brand NameNOVA -S SAPPHIRE BRACKET
Version Model Number466-445
Catalog Number466-445
Company DUNS020956330
Company NameOrtho Arch Company Inc
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 Datefalse
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
HIBCCD9094664450 [Primary]

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 Date2023-07-03
Device Publish Date2023-06-23

Devices Manufactured by Ortho Arch Company Inc

D9098001290 - SPECTRUM2023-07-06 SPECTRUM LINGUAL ARCH FORMING PLIER
D9098001302 - SPECTRUM 2023-07-06 SPECTRUM TORQUING PLIER SET W/ WIDE KEY
D9098001311 - SPECTRUM2023-07-06 SPECTRUM WIDE REPLACEMENT KEY
D9098001321 - SPECTRUM2023-07-06 SPECTRUM THREE PRONG FACEMASK/ FACEBOW PLIER
D90980014111 - MOLAR OPENING TOOL2023-07-06 SLB MOLAR OPENING TOOL
D90980014616 - OPENING TOOL2023-07-06 ECLIPSE SLB OPENING TOOL
D90980014717 - CLOSING TOOL2023-07-06 ECLIPSE SLB CLOSING TOOL
D90980014818 - ECLIPSE SLB CLOSING TOOL2023-07-06 ECLIPSE SLB CLOSING TOOL W/ WIRE DIRECTOR

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