CS 8100 5303060

GUDID 60192155303067

CS 8100 ACCESS 110V 230V

CARESTREAM DENTAL LLC

Stationary extraoral dental x-ray system, digital
Primary Device ID60192155303067
NIH Device Record Key1a67c72b-abbc-4e7d-b581-3a83ab2beec9
Commercial Distribution StatusIn Commercial Distribution
Brand NameCS 8100
Version Model NumberCS 8100
Catalog Number5303060
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
GS160192155303067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUHSystem, X-Ray, Extraoral Source, Digital

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-06-07
Device Publish Date2018-10-24

On-Brand Devices [CS 8100]

60192155311321CS 8100
60192155303067CS 8100 ACCESS 110V 230V
60192155303043CS 8100 110V 230V

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