DRX Plus 2530C Detector 8615205

GUDID 60889978615209

DRX PLUS 2530C DETECTOR/ ASCEND

CARESTREAM HEALTH, INC.

Indirect flat panel x-ray detector
Primary Device ID60889978615209
NIH Device Record Key178fbed9-3d9b-4c91-b5df-bba07f988e63
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRX Plus 2530C Detector
Version Model NumberDRX Plus 2530C Detector
Catalog Number8615205
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
GS160889978615209 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-17
Device Publish Date2021-08-09

On-Brand Devices [DRX Plus 2530C Detector]

60889978615209DRX PLUS 2530C DETECTOR/ ASCEND
60889975950419PACKED, DETECTOR, 2530 C

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