CARESTREAM DRX-EVOLUTION 1731678

GUDID 60889971731678

DRX-EVOLUTION/P-PCSH-P-X

CARESTREAM HEALTH, INC.

Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital
Primary Device ID60889971731678
NIH Device Record Key0e04357f-55fa-421d-a148-334550cf4aab
Commercial Distribution StatusIn Commercial Distribution
Brand NameCARESTREAM DRX-EVOLUTION
Version Model NumberCARESTREAM DRX-EVOLUTION
Catalog Number1731678
Company DUNS793169512
Company NameCARESTREAM HEALTH, INC.
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
GS160889971731678 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPRSystem, x-ray, stationary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

On-Brand Devices [CARESTREAM DRX-EVOLUTION]

60889978001231DRX-EVOLUTION/P-PCSH-P-X W/WP
60889978001194DRX-EVOLUTION/P-PCSH-P-X W/INWP
60889978001170DRX-EVOLUTION/P-PCSH-P-X
60889976565667ASSM-UNIVERSAL GRID HOLDER, DRX-EVOLUTIO
60889976557655CARESTREAM DRX BABIX HOLDER
60889976551523MOVEABLE TABLE FOR DR SYS
6088997196378980KW GENERATOR/FOR DRX-EVOLUTION
60889971731678DRX-EVOLUTION/P-PCSH-P-X
60889971731623DRX-EVOLUTION/B-BCSH-P-X
60889971051301GRID/DRX-EVO WALL 140CM 8:1/40 LN/CM
60889971035745DRX-EVO 80 kW GENERATOR STANDARD/Q
60889971035738DRX-EVO 65 kW GENERATOR STANDARD/Q

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