TDR 3543 Detector AB3964

GUDID 60889974000177

AY-DETECTOR, COMPLETE, TDR3543

CARESTREAM HEALTH, INC.

Indirect flat panel x-ray detector
Primary Device ID60889974000177
NIH Device Record Keyede45f8b-961c-4941-9b27-1e024af3cd55
Commercial Distribution StatusIn Commercial Distribution
Brand NameTDR 3543 Detector
Version Model NumberTDR 3543 Detector
Catalog NumberAB3964
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
GS160889974000177 [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

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