Exprimer

GUDID 08800018406106

The EVS 3643WG Digital X-ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.

DRTECH Corporation

Indirect flat panel x-ray detector
Primary Device ID08800018406106
NIH Device Record Keyd9accdc0-670f-4593-8eeb-0801b1cec09a
Commercial Distribution StatusIn Commercial Distribution
Brand NameExprimer
Version Model NumberEVS 3643WG
Company DUNS689842626
Company NameDRTECH Corporation
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 Datetrue
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
GS108800018406106 [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 Date2019-12-05
Device Publish Date2019-11-27

On-Brand Devices [Exprimer]

08800018404508The EVS 2430GW Digital X-ray detector is designed as a digital imaging solution, for providing g
08800018404409The EVS 2430W Digital X-ray detector is designed as a digital imaging solution, for providing ge
08800018403501The EVS 4343 Detector is an indirect conversion device in the form of a square plate in which co
08800018403402The EVS 4343G Detector is an indirect conversion device in the form of a square plate in which c
08800018402702The EVS 3643G Detector is an indirect conversion device in the form of a square plate in which c
08800018402603The EVS 3643 detector is an indirect conversion device in the form of a square plate in which co
08800018405703EVS 3643AG
08800018405604EVS 3643A
08800018405505EVS 4343AG
08800018405406EVS 4343A
08800018406502The EVS 4343WP Digital X-ray detector is indicated for digital imaging solution designed for pro
08800018406304The EXPD 4343P Digital X-ray detector is indicated for digital imaging solution designed for pro
08800018406106The EVS 3643WG Digital X-ray detector is indicated for digital imaging solution designed for pro
08800018406007The EVS 3643W Digital X-ray detector is indicated for digital imaging solution designed for prov
08800018405901The EVS 4343WG Digital X-ray detector is indicated for digital imaging solution designed for pro
08800018405802The EVS 4343W Digital X-ray detector is indicated for digital imaging solution designed for prov
08800018406403The EVS 3643WP Digital X-ray detector is indicated for digital imaging solution designed for pro
08800018406205The EXPD 3643P Digital X-ray detector is indicated for digital imaging solution designed for pro

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