DR 400 58UCJ

GUDID 05414904217870

DR 400 5520/200 Automatic

AGFA

Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 05414904217870
• NIH Device Record Key: 968ce898-3f69-4af1-94c9-c0cc845fbd50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DR 400
• Version Model Number: 5520/200
• Catalog Number: 58UCJ
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414904217870 [Primary]

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: 3
• Public Version Date: 2019-06-14
• Device Publish Date: 2016-09-16

On-Brand Devices [DR 400]

• 05414904217870: DR 400 5520/200 Automatic
• 05414904176252: DR 400 SYSTEM
• 05414904281321: 5520/150