CR MD4.0T GENERAL SET EVHC1

GUDID 05414904017326

CR MD4.0T GENERAL SET 15CM X 30CM

AGFA

Digital imaging cassette/storage phosphor screen Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray

• Primary Device ID: 05414904017326
• NIH Device Record Key: 16945434-9182-43ea-867d-aa4313fd7fcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CR MD4.0T GENERAL SET
• Version Model Number: CR MD4.0T GENERAL SET 15X30
• Catalog Number: EVHC1
• Company DUNS: 374444883
• Company Name: AGFA
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com

Device Dimensions

• Length: 15 Centimeter
• Length: 15 Centimeter
• Width: 30 Centimeter
• Length: 15 Centimeter
• Width: 30 Centimeter
• Length: 15 Centimeter
• Width: 30 Centimeter
• Length: 15 Centimeter
• Width: 30 Centimeter
• Length: 15 Centimeter
• Width: 30 Centimeter
• Length: 15 Centimeter
• Width: 30 Centimeter
• Length: 15 Centimeter
• Width: 30 Centimeter
• Length: 15 Centimeter
• Width: 30 Centimeter
• Length: 15 Centimeter
• Width: 30 Centimeter
• Length: 15 Centimeter
• Width: 30 Centimeter
• Length: 15 Centimeter
• Width: 30 Centimeter
• Length: 15 Centimeter
• Width: 30 Centimeter
• Length: 15 Centimeter
• Width: 30 Centimeter
• Length: 15 Centimeter
• Width: 30 Centimeter
• Length: 15 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414904017326 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062223

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: 4
• Public Version Date: 2019-06-14
• Device Publish Date: 2016-09-01

On-Brand Devices [CR MD4.0T GENERAL SET]

• 05414904044308: CR MD4.0T GENERAL SET 35CM X 35CM
• 05414904017340: CR MD4.0T GENERAL SET 24CM X 30CM
• 05414904017333: CR MD4.0T GENERAL SET 18CM X 24CM
• 05414904017326: CR MD4.0T GENERAL SET 15CM X 30CM
• 05414904017098: CR MD4.0T GENERAL SET 35CM X 43CM