CS 8100SC 5314562

GUDID 60192155314568

SC UPGRADE FOR CS 8100

CARESTREAM DENTAL LLC

Stationary cephalometric x-ray system, digital
Primary Device ID60192155314568
NIH Device Record Key076e2077-4eae-4440-88fe-e488c2db3dfd
Commercial Distribution StatusIn Commercial Distribution
Brand NameCS 8100SC
Version Model NumberCS 8100SC
Catalog Number5314562
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
GS160192155314568 [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 Number5
Public Version Date2019-06-07
Device Publish Date2018-01-15

On-Brand Devices [CS 8100SC]

60192155314568SC UPGRADE FOR CS 8100
60192155314346CS 8100SC

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