DRX-Transportable System 8604787

GUDID 60889978604784

DRX-TRANSPORTABLE SYSTEM /LITE

CARESTREAM HEALTH, INC.

Indirect flat panel x-ray detector
Primary Device ID60889978604784
NIH Device Record Keyaa9b6680-f149-4dee-bf00-2fc9c6278b0f
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRX-Transportable System
Version Model NumberDRX-Transportable System
Catalog Number8604787
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
GS160889978604784 [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 Number3
Public Version Date2019-05-07
Device Publish Date2018-09-30

On-Brand Devices [DRX-Transportable System]

60889978604784DRX-TRANSPORTABLE SYSTEM /LITE
60889971021281DRX-TRANS/FIELDPORT-DRX-1&-1CW/30DAYWAR
60889971021250DRX-TRANSPORTSYS/UNIVMOBILEDRX-1&1C
60889978619986DRX-TRANSPORTABLE SYSTEM/LITE

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