CS 8100 3D 5942123

GUDID 60192155942129

CS 8100 3D Select

CARESTREAM DENTAL LLC

Cone beam computed tomography system, head/neck
Primary Device ID60192155942129
NIH Device Record Key62b1104b-c95d-441d-a339-be85ffda534d
Commercial Distribution StatusIn Commercial Distribution
Brand NameCS 8100 3D
Version Model NumberCS 8100 3D
Catalog Number5942123
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

Device Identifiers

Device Issuing AgencyDevice ID
GS160192155942129 [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 Number3
Public Version Date2019-10-28
Device Publish Date2019-05-10

On-Brand Devices [CS 8100 3D]

60192155500312CS 8100 3D
60192155942129CS 8100 3D Select

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