CS 7600 1018902

GUDID 60192151018903

CS 7600 SMART PLATE STARTER KIT

CARESTREAM DENTAL LLC

Dental computed radiography digital imaging scanner
Primary Device ID60192151018903
NIH Device Record Keyb9dbaedd-ad22-4562-a05d-d916167b6c50
Commercial Distribution StatusIn Commercial Distribution
Brand NameCS 7600
Version Model NumberCS 7600
Catalog Number1018902
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 Batchtrue
Serial Numberfalse
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
GS140192151018909 [Primary]
GS160192151018903 [Package]
Contains: 40192151018909
Package: [20 Units]
In Commercial Distribution

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 Number4
Public Version Date2019-06-07
Device Publish Date2019-03-01

On-Brand Devices [CS 7600]

60192151068403CS7600 Imaging System for US, CA, Brazil
60192151014318CS 7600 SCAN&GO DEVICE
60192151014301CS 7600 INTRAORAL IMAGING PLATE SYS
60192151018903CS 7600 SMART PLATE STARTER KIT
60192155942730CS 7600 IMAGING PLATE SYSTEM

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