CEPHALOSTAT 5211016

GUDID 60192155211010

CEPH UPGRADE FOR 9X00 FAMILY

CARESTREAM DENTAL LLC

Stationary cephalometric x-ray system, digital
Primary Device ID60192155211010
NIH Device Record Key05cc884f-bd00-4b2b-a69c-506180736035
Commercial Distribution StatusIn Commercial Distribution
Brand NameCEPHALOSTAT
Version Model NumberCEPHALOSTAT
Catalog Number5211016
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS160192155211010 [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

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 Access2023-12-20 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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