CR HD5.0 GENERAL DETECTOR ERMRE

GUDID 05414904015629

CR HD5.0 GENERAL DETECTOR 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: 05414904015629
• NIH Device Record Key: 9db96a5c-0186-40f7-b809-2c20f0ee6f93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CR HD5.0 GENERAL DETECTOR
• Version Model Number: CR HD5.0 GENERAL DETECTOR 18X24
• Catalog Number: ERMRE
• 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: 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: 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	05414904015629 [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 HD5.0 GENERAL DETECTOR]

• 05414904015650: CR HD5.0 GENERAL DETECTOR 35CM X 43CM
• 05414904015636: CR HD5.0 GENERAL DETECTOR 24X30CM
• 05414904015629: CR HD5.0 GENERAL DETECTOR 18X24
• 05414904015612: CR HD5.0 GENERAL DETECTOR 15X30