CS 9300 5319728

GUDID 60192155319723

CS 9300 110V

CARESTREAM DENTAL LLC

Cone beam computed tomography system, head/neck
Primary Device ID60192155319723
NIH Device Record Key5e518b1e-e2b5-40f6-9c11-660b3bf59aee
Commercial Distribution StatusIn Commercial Distribution
Brand NameCS 9300
Version Model NumberCS 9300
Catalog Number5319728
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
GS160192155319723 [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 Number5
Public Version Date2019-06-07
Device Publish Date2018-01-15

On-Brand Devices [CS 9300]

60192155319723CS 9300 110V
60192155319686CS 9300 230V

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