CR MD4.0R GENERAL SR SET E49V7

GUDID 05414904026571

CR MD4.0R GENERAL SR SET 35CM X 43CM

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: 05414904026571
• NIH Device Record Key: f5edf4f4-f30e-4f0b-8da5-62087fbd9a2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CR MD4.0R GENERAL SR SET
• Version Model Number: CR MD4.0R GENERAL SR SET 35X43
• Catalog Number: E49V7
• 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: 35 Centimeter
• Length: 35 Centimeter
• Width: 43 Centimeter
• Length: 35 Centimeter
• Width: 43 Centimeter
• Length: 35 Centimeter
• Width: 43 Centimeter
• Length: 35 Centimeter
• Width: 43 Centimeter
• Length: 35 Centimeter
• Width: 43 Centimeter
• Length: 35 Centimeter
• Width: 43 Centimeter
• Length: 35 Centimeter
• Width: 43 Centimeter
• Length: 35 Centimeter
• Width: 43 Centimeter
• Length: 35 Centimeter
• Width: 43 Centimeter
• Length: 35 Centimeter
• Width: 43 Centimeter
• Length: 35 Centimeter
• Width: 43 Centimeter
• Length: 35 Centimeter
• Width: 43 Centimeter
• Length: 35 Centimeter
• Width: 43 Centimeter
• Length: 35 Centimeter
• Width: 43 Centimeter
• Length: 35 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414904026571 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141602

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 MD4.0R GENERAL SR SET]

• 05414904026588: CR MD4.0R GENERAL SR SET.35CM X 35CM
• 05414904026571: CR MD4.0R GENERAL SR SET 35CM X 43CM