DRX Core 3543C Detector AD8201

GUDID 60889974008470

AY-PACKED, DRX CORE, 3543C

CARESTREAM HEALTH, INC.

Indirect flat panel x-ray detector Indirect flat panel x-ray detector
Primary Device ID60889974008470
NIH Device Record Key79ced2b9-8079-4765-b18c-17fdb94387ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRX Core 3543C Detector
Version Model NumberDRX Core 3543C Detector
Catalog NumberAD8201
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
GS160889974008470 [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 Number6
Public Version Date2019-05-07
Device Publish Date2016-09-16

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