DRX-Revolution Mobile X-ray System 1019405

GUDID 60889971019400

TUBE-GRID ALIGN SYS FOR DRX-REVOLUTION

CARESTREAM HEALTH, INC.

Mobile basic diagnostic x-ray system, digital
Primary Device ID60889971019400
NIH Device Record Key140fa5ac-96a9-45eb-b8d0-487064bed6d8
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRX-Revolution Mobile X-ray System
Version Model NumberDRX-Revolution Mobile X-ray System
Catalog Number1019405
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
GS160889971019400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IZLSystem, x-ray, mobile

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-Revolution Mobile X-ray System]

60889978612499DRX-REVOLUTION W/TOSHIBA TUBE&CSH GEN
60889978007257DRX-MOBILE CONSOLE
60889975950013MOBILE X-RAY GENERATOR
60889971060174DRX-REVOLUTION MOBILE X-RAY SYSTEM
60889971019400TUBE-GRID ALIGN SYS FOR DRX-REVOLUTION
60889971019394DRX-REVOLUTION MOBILE X-RAY SYSTEM
60889971002631DRX-MOBILE CONSOLE
60889978618897DRX REVOLUTION MOBILE X-RAY SYSTEM

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