TDR 3543C Detector 1067321

GUDID 60889971067326

TDR 3543C DETECTOR / FOR DIRECTVIEW SW

CARESTREAM HEALTH, INC.

Indirect flat panel x-ray detector
Primary Device ID60889971067326
NIH Device Record Keya42271f4-f741-4b43-aac9-343e52ee87a2
Commercial Distribution StatusIn Commercial Distribution
Brand NameTDR 3543C Detector
Version Model NumberTDR 3543C Detector
Catalog Number1067321
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
GS160889971067326 [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 [TDR 3543C Detector]

60889974000184AY-DETECTOR, COMPLETE, TDR3543C
60889971067326TDR 3543C DETECTOR / FOR DIRECTVIEW SW

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