CS 3600 5942149

GUDID 60192155942143

3D I/O SCANNER, CS 3600 SDC

CARESTREAM DENTAL LLC

Dental CAD/CAM system, chairside
Primary Device ID60192155942143
NIH Device Record Keya7a87dfd-68d7-48ae-9d14-4e1ca2c67633
Commercial Distribution StatusIn Commercial Distribution
Brand NameCS 3600
Version Model NumberCS 3600
Catalog Number5942149
Company DUNS019796106
Company NameCARESTREAM DENTAL LLC
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 Usefalse
Lot Batchfalse
Serial Numbertrue
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
GS160192155942143 [Primary]

FDA Product Code

NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-10
Device Publish Date2019-07-19

On-Brand Devices [CS 3600]

60192156577894CS 3600 POSTERIOR TIP KIT
60192156577153CS3600 ACCESS I/O 3D SCANNER
60192156568748CS 3600 I/O 3D SCANNER
60192155950032CS 3600 POSTERIOR TIP
60192155950025CS 3600 ACCESS HANDPIECE
60192155942341CS 3600 I/O SCANNER W/CS SCANFLOW
601921559421433D I/O SCANNER, CS 3600 SDC

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