TRIMAX 43C 6702344

GUDID 60889976702345

TRIMAX 43C DETECTOR

CARESTREAM HEALTH, INC.

Indirect flat panel x-ray detector
Primary Device ID60889976702345
NIH Device Record Key9af875a9-dc85-4a42-876c-0823dff22940
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRIMAX 43C
Version Model NumberTRIMAX 43C
Catalog Number6702344
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
GS160889976702345 [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 Date2020-12-14
Device Publish Date2020-12-06

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