Bracketizer Instrument

GUDID 00190707102388

Bracketizer Instrument

ORTHO ORGANIZERS, INC.

Orthodontic pliers
Primary Device ID00190707102388
NIH Device Record Key8befeffc-c423-43fe-80c1-0d47607675e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameBracketizer Instrument
Version Model Number200-329
Company DUNS062165188
Company NameORTHO ORGANIZERS, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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
GS100190707102388 [Primary]

FDA Product Code

ECQALIGNER, BRACKET, ORTHODONTIC

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-25
Device Publish Date2022-10-17

Devices Manufactured by ORTHO ORGANIZERS, INC.

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