CARESTREAM DRX-1 System 1003698

GUDID 60889971003690

DRX-1C MOBILE CONSOLE

CARESTREAM HEALTH, INC.

Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector
Primary Device ID60889971003690
NIH Device Record Key021f4716-8124-4a92-855e-91ee07c9ddda
Commercial Distribution StatusIn Commercial Distribution
Brand NameCARESTREAM DRX-1 System
Version Model NumberCARESTREAM DRX-1 System
Catalog Number1003698
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
GS160889971003690 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQBSolid state x-ray imager (flat panel/digital imager)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-05-07
Device Publish Date2016-09-16

On-Brand Devices [CARESTREAM DRX-1 System]

60889971039187QRAD DRX REFRESHED CONSOLE W/WP
60889971035158DRX-1 SYS CONSOLE ONLY W/DRX-1 SYS SW
60889971021229CARESTREAM DRX-1 SYSTEM
60889971003812DRX-1C MOBILE CONSOLE
60889971003690DRX-1C MOBILE CONSOLE
60889978622795CARESTREAM DRX-1 SYSTEM
60889978625925DRX-1 SYSTEM CONSOLE UPGRADE

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