DRX-Evolution Plus System 1035146

GUDID 60889971035141

DRX-EVO MOTOR CSH WS ONLY/X-PCSH4343-X-X

CARESTREAM HEALTH, INC.

Stationary basic diagnostic x-ray system, digital
Primary Device ID60889971035141
NIH Device Record Key4a95e939-cd55-4367-944c-983db3d6e2a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRX-Evolution Plus System
Version Model NumberDRX-Evolution Plus System
Catalog Number1035146
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
GS160889971035141 [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 [DRX-Evolution Plus System]

60889978602773FIBRE GRID DRX-EVO WALL 180CM10:1 40LPCM
60889971739254DRX-EVOLUTION Plus - CSH WS w SLIM E-BOX
60889971739247Elevating Table (320) - DRX Evo Plus
60889971739230Elevating Table - DRX Evo Plus
60889971739193DRX-Evolution Plus Automatic - Dual Buck
60889971035141DRX-EVO MOTOR CSH WS ONLY/X-PCSH4343-X-X
60889971026170DRX-EVOLUTN PREMIUM CSH WS W/ SLIM E-BOX
60889971016140DRX EVO FIXD ELE TBL MDL VX3733-TAB
60889971741035DRX-Evolution Plus System (B-PCSH-P-X)
60889971739469DRX-Evolution Plus Transbay OTC System
60889971739223DRX-Evolution Plus System (P-X-P-X)
60889971739216DRX-Evolution Plus System (P-PCSCH-X-X)

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