DR 800 XCTMA

GUDID 05414904251805

DR System

AGFA

Stationary general-purpose fluoroscopic x-ray system, digital

• Primary Device ID: 05414904251805
• NIH Device Record Key: 96ab85bb-4c80-47b2-8079-282d7329e950
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DR 800
• Version Model Number: 6010/200
• Catalog Number: XCTMA
• 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	05414904251805 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180589

FDA Product Code

• JAA: System, x-ray, fluoroscopic, image-intensified

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: 2018-06-02

Devices Manufactured by AGFA

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• 05414904233320 - NX 4.0: 2023-07-26
• 05414904281321 - DR 400: 2023-03-31
• 05414904225066 - Mamoray HDR-C Plus: 2022-11-24
• 05414904231678 - Dentus M2 Comfort: 2022-11-24
• 05414904231692 - Dentus M2 Comfort: 2022-11-24
• 05414904231531 - Dentus Ortholux Register: 2022-11-14