Risas Reveal® Aligners

GUDID 00190707090630

Risas Reveal® Aligners Retainer Case

ORTHO ORGANIZERS, INC.

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Primary Device ID00190707090630
NIH Device Record Keyf25df154-75b3-42d9-be67-f602dbaf491d
Commercial Distribution StatusIn Commercial Distribution
Brand NameRisas Reveal® Aligners
Version Model Number133-CASE
Company DUNS062165188
Company NameORTHO ORGANIZERS, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
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 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
GS100190707090630 [Primary]

FDA Product Code

NXCAligner, sequential

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-22
Device Publish Date2021-07-14

On-Brand Devices [Risas Reveal® Aligners]

00190707090630Risas Reveal® Aligners Retainer Case
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00190707090210Risas Reveal® Aligners
00190707090203Risas Reveal® Aligners
00190707090197Risas Reveal® Aligners
00190707090180Risas Reveal® Aligners
00190707090173Risas Reveal® Aligners
00190707090166Risas Reveal® Aligners
00190707090159Risas Reveal® Aligners
00190707090142Risas Reveal® Aligners

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