CS 8100 3D 5500319

GUDID 60192155500312

CS 8100 3D

CARESTREAM DENTAL LLC

Stationary extraoral dental x-ray system, digital
Primary Device ID60192155500312
NIH Device Record Key0e76349e-75c6-4487-976b-b68ee26fbaad
Commercial Distribution StatusIn Commercial Distribution
Brand NameCS 8100 3D
Version Model NumberCS 8100 3D
Catalog Number5500319
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
GS160192155500312 [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 8100 3D]

60192155500312CS 8100 3D
60192155942129CS 8100 3D Select

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