DRX Plus 4343 DETECTOR AD4400

GUDID 60889974007510

AY-PACKED, 4343 DETECTOR, DRX PLUS

CARESTREAM HEALTH, INC.

Indirect flat panel x-ray detector Indirect flat panel x-ray detector
Primary Device ID60889974007510
NIH Device Record Key640f1aec-fcff-4254-8d33-c781aa85bb88
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRX Plus 4343 DETECTOR
Version Model NumberDRX Plus 4343 DETECTOR
Catalog NumberAD4400
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
GS160889974007510 [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 [DRX Plus 4343 DETECTOR]

60889974007510AY-PACKED, 4343 DETECTOR, DRX PLUS
60889971746146DRX Plus 4343 portable grid holder
60889975950556PACKED, 4343 DETECTOR, DRX PLUS

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