DR 14s C DX-D IMAGING PACKAGE XBOOK

GUDID 05414904222201

AGFA

Flat panel x-ray detector integration unit

• Primary Device ID: 05414904222201
• NIH Device Record Key: 4a317ef5-d0f2-4a8d-8ea4-9c1b828a81cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DR 14s C DX-D IMAGING PACKAGE
• Version Model Number: 5400/523
• Catalog Number: XBOOK
• 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

Device Dimensions

• Length: 43 Centimeter
• Length: 43 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414904222201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161368

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: 5
• Public Version Date: 2019-06-14
• Device Publish Date: 2016-12-23

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• 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