Orthodontic Instrument

GUDID 00190707089849

Bracket Placer / Slot Aligner

ORTHO ORGANIZERS, INC.

Orthodontic pliers
Primary Device ID00190707089849
NIH Device Record Key1fa7221e-ab04-41db-b923-04e5db9af397
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrthodontic Instrument
Version Model Number200-322
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
GS100190707089849 [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

On-Brand Devices [Orthodontic Instrument]

00190707064532.018 BRACKET HEIGHT GAUGE INSTRUMENT DOUBLE ENDED
001907070647613-PRONG FACEBOW PLIER
00190707089849Bracket Placer / Slot Aligner
00190707096977Abrasive Strip Placer

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