TRIMAX 4343FC Detector AE4207

GUDID 60889974160239

AY-DETECTOR, PACKED, 4343FC, TRIMAX

CARESTREAM HEALTH, INC.

Indirect flat panel x-ray detector Indirect flat panel x-ray detector
Primary Device ID60889974160239
NIH Device Record Key7d99c5d6-d8f1-4114-b9f5-5b0aca5e8511
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRIMAX 4343FC Detector
Version Model NumberDETECTOR,PACKED,TRIMAX,4343FC
Catalog NumberAE4207
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
GS160889974160239 [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 Date2017-05-23

Devices Manufactured by CARESTREAM HEALTH, INC.

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