DRX-1C Detector AB5213

GUDID 60889974000801

AY-PKD-DRX-1C DETECTOR-CHINA

CARESTREAM HEALTH, INC.

Indirect flat panel x-ray detector Indirect flat panel x-ray detector
Primary Device ID60889974000801
NIH Device Record Key14330122-980c-4a38-95e6-98c05b07acfa
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRX-1C Detector
Version Model NumberDRX-1C Detector
Catalog NumberAB5213
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
GS160889974000801 [Primary]

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 Number4
Public Version Date2019-05-07
Device Publish Date2016-09-16

On-Brand Devices [DRX-1C Detector]

60889974000801AY-PKD-DRX-1C DETECTOR-CHINA
60889974000191AY-DETECTOR, DRX-1C, OEM, PACKED
60889974000160AY-DETECTOR, COMPLETE, DRX 1-C

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