SCAN CEPH 5943238

GUDID 60192155943232

SCAN CEPH FOR CS 8200 3D

CARESTREAM DENTAL LLC

Cone beam computed tomography system, head/neck
Primary Device ID60192155943232
NIH Device Record Keyb85f1358-e1cf-49eb-bf04-cac91760dfb2
Commercial Distribution StatusIn Commercial Distribution
Brand NameSCAN CEPH
Version Model Number5943238
Catalog Number5943238
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS160192155943232 [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 Date2020-06-30
Device Publish Date2020-06-22

On-Brand Devices [SCAN CEPH]

60192155500435SCAN CEPH UPGRADE FOR CS 8100 3D
60192155942396SCAN CEPH FOR CS 9600
60192155943232SCAN CEPH FOR CS 8200 3D

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