CR MD1.0 GENERAL SET 5YEFP

GUDID 05414904160718

CR MD1.0 GENERAL SET 18X24

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: 05414904160718
• NIH Device Record Key: b86291f9-8f3e-456b-817c-75dd03196bbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CR MD1.0 GENERAL SET
• Version Model Number: CR MD1.0 GENERAL SET 18X24
• Catalog Number: 5YEFP
• 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: false
• Expiration Date: true
• 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

• Width: 24 Centimeter
• Width: 24 Centimeter
• Length: 18 Centimeter
• Width: 24 Centimeter
• Length: 18 Centimeter
• Width: 24 Centimeter
• Length: 18 Centimeter
• Width: 24 Centimeter
• Length: 18 Centimeter
• Width: 24 Centimeter
• Length: 18 Centimeter
• Width: 24 Centimeter
• Length: 18 Centimeter
• Width: 24 Centimeter
• Length: 18 Centimeter
• Width: 24 Centimeter
• Length: 18 Centimeter
• Width: 24 Centimeter
• Length: 18 Centimeter
• Width: 24 Centimeter
• Length: 18 Centimeter
• Width: 24 Centimeter
• Length: 18 Centimeter
• Width: 24 Centimeter
• Length: 18 Centimeter
• Width: 24 Centimeter
• Length: 18 Centimeter
• Width: 24 Centimeter
• Length: 18 Centimeter
• Width: 24 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414904160718 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131408

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 MD1.0 GENERAL SET]

• 05414904209752: CR MD1.0 GENERAL SET 35X35
• 05414904160725: CR MD1.0 GENERAL SET 15X30
• 05414904160718: CR MD1.0 GENERAL SET 18X24
• 05414904160701: CR MD1.0 GENERAL SET 24X30
• 05414904092521: CR MD1.0 GENERAL SET 35X43