CS Model+ 5942719

GUDID 60192155942716

CS MODEL+

CARESTREAM DENTAL LLC

CAD/CAM software
Primary Device ID60192155942716
NIH Device Record Key226df3ec-4e3f-4468-b1c0-b68b126e5eaf
Commercial Distribution StatusIn Commercial Distribution
Brand NameCS Model+
Version Model NumberCS Model+
Catalog Number5942719
Company DUNS019796106
Company NameCARESTREAM DENTAL LLC
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 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
GS160192155942716 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PNNOrthodontic Software

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-05
Device Publish Date2020-04-27

On-Brand Devices [CS Model+]

60192155942716CS MODEL+
60192155944482LICENCE CS MODEL+ V5 ALIGNER CAPABILITY

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