CS 9300C 5319736

GUDID 60192155319730

CS 9300C 110V

CARESTREAM DENTAL LLC

Cone beam computed tomography system, head/neck
Primary Device ID60192155319730
NIH Device Record Key13e3404b-220f-4df6-8e1a-06bae63de6c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameCS 9300C
Version Model NumberCS 9300C
Catalog Number5319736
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS160192155319730 [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 Number6
Public Version Date2019-12-10
Device Publish Date2018-01-15

On-Brand Devices [CS 9300C]

60192155319730CS 9300C 110V
60192155319693CS 9300C 230V

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