DX-D 100 5R78W

GUDID 05414904094440

DX-D 100 MOB WLS DR 50KW (300KHU)/110V

AGFA

Mobile basic diagnostic x-ray system, digital

• Primary Device ID: 05414904094440
• NIH Device Record Key: eb1b9794-0f25-497e-b894-b343ce3ab2e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DX-D 100
• Version Model Number: 5411/050
• Catalog Number: 5R78W
• 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	05414904094440 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103597

FDA Product Code

• IZL: System, x-ray, mobile

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 [DX-D 100]

• 05414904202357: DX-D 100 - DX-D40/45 - 50 KW-300KHU-110V
• 05414904094440: DX-D 100 MOB WLS DR 50KW (300KHU)/110V
• 05414904080078: DX-D 100 MOBILE DR 50KW (300 KHU/)110V