Exprimer

GUDID 08800018402603

The EVS 3643 detector is an indirect conversion device in the form of a square plate in which converts the incoming X-rays into visible light.

DRTECH Corporation

Indirect flat panel x-ray detector

• Primary Device ID: 08800018402603
• NIH Device Record Key: fa5e5ab2-784d-413b-b8d4-2111260779f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exprimer
• Version Model Number: EVS 3643
• Company DUNS: 689842626
• Company Name: DRTECH Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800018402603 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162552

FDA Product Code

• MQB: Solid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2019-11-26
• Device Publish Date: 2016-09-02

On-Brand Devices [Exprimer]

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