SCAN CEPH 5500434

GUDID 60192155500435

SCAN CEPH UPGRADE FOR CS 8100 3D

CARESTREAM DENTAL LLC

Stationary cephalometric x-ray system, digital Stationary cephalometric x-ray system, digital
Primary Device ID60192155500435
NIH Device Record Key99384e2d-2d81-4ff2-929a-4575f588abf3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSCAN CEPH
Version Model NumberSCAN CEPH
Catalog Number5500434
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
GS160192155500435 [Primary]

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 Number4
Public Version Date2019-06-07
Device Publish Date2018-01-15

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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