CS 8200 3D Access 5944863

GUDID 60192155944864

CS 8200 3D ACCESS

CARESTREAM DENTAL LLC

Cone beam computed tomography system, head/neck
Primary Device ID60192155944864
NIH Device Record Keydc87d80f-b0bc-4db2-8c53-36c17ffca1bc
Commercial Distribution StatusIn Commercial Distribution
Brand NameCS 8200 3D Access
Version Model Number5944863
Catalog Number5944863
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
GS160192155944864 [Primary]

FDA Product Code

MUHSystem, X-Ray, Extraoral Source, Digital

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-20
Device Publish Date2023-12-12

Devices Manufactured by CARESTREAM DENTAL LLC

60192155945076 - RIOSensor+2024-01-25 RIOSensor+ Size 1
60192155945083 - RIOSENSOR+2024-01-25 RIOSENSOR+ SIZE 2
60192155944864 - CS 8200 3D Access2023-12-20CS 8200 3D ACCESS
60192155944864 - CS 8200 3D Access2023-12-20 CS 8200 3D ACCESS
60192155944833 - DENTRA III2023-06-12 DENTRA III SIZE 1
60192155944840 - DENTRA III2023-06-12 DENTRA III SIZE 2
60192155944543 - Swissmeda powered by Carestream Dental2022-10-31 Swissmeda powered by Carestream Dental
60192155943720 - CS 3800 Wired2022-02-21 CS 3800 3D I/O SCANNER WIRED
60192155944482 - CS Model+2021-11-15 LICENCE CS MODEL+ V5 ALIGNER CAPABILITY

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