DRX 2530C DETECTOR 9J2791

GUDID 60889974000078

AY-DETECTOR-PACKED-25X30

CARESTREAM HEALTH, INC.

Indirect flat panel x-ray detector
Primary Device ID60889974000078
NIH Device Record Key5c8dfddf-ba8e-4f56-abea-464d77b835e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRX 2530C DETECTOR
Version Model NumberDRX 2530C DETECTOR
Catalog Number9J2791
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
GS160889974000078 [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 Number8
Public Version Date2020-06-29
Device Publish Date2016-09-16

On-Brand Devices [DRX 2530C DETECTOR]

60889974000795AY-DETECTOR-2530-COMPLETE-OEM
60889974000078AY-DETECTOR-PACKED-25X30
60889975950525PACKED, DETECTOR, 2530 C

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