CS 9300 Select 5319710

GUDID 60192155319716

CS 9300 SELECT 230V

CARESTREAM DENTAL LLC

Cone beam computed tomography system, head/neck
Primary Device ID60192155319716
NIH Device Record Keyb07045b7-0c83-484d-a6e9-425e07e219d1
Commercial Distribution StatusIn Commercial Distribution
Brand NameCS 9300 Select
Version Model NumberCS 9300 Select
Catalog Number5319710
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 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
GS160192155319716 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OASX-ray, tomography, computed, dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number7
Public Version Date2019-10-28
Device Publish Date2018-01-15

On-Brand Devices [CS 9300 Select]

60192155319747CS 9300 SELECT 110V
60192155319716CS 9300 SELECT 230V

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