Del Medical

GUDID 00858340006004

This a motorized mobile diagnostic x-ray system. The Mobile Direct Radiographic system facilitates x-ray examinations, in situations where it is not feasible to transport the patient to a ward with fixed equipment. The unit is precise, yet easy to maneuver due to smooth battery-powered motorization

Del Medical, Inc.

Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital

• Primary Device ID: 00858340006004
• NIH Device Record Key: f00f0daa-4b42-4d6c-8532-6bb95fb955bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Del Medical
• Version Model Number: MDR
• Company DUNS: 078671236
• Company Name: Del Medical, Inc.
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 847-288-7031
• Email: ggeary@delmedical.com
• Phone: 847-288-7031
• Email: ggeary@delmedical.com
• Phone: 847-288-7031
• Email: ggeary@delmedical.com
• Phone: 847-288-7031
• Email: ggeary@delmedical.com
• Phone: 847-288-7031
• Email: ggeary@delmedical.com
• Phone: 847-288-7031
• Email: ggeary@delmedical.com
• Phone: 847-288-7031
• Email: ggeary@delmedical.com
• Phone: 847-288-7031
• Email: ggeary@delmedical.com
• Phone: 847-288-7031
• Email: ggeary@delmedical.com
• Phone: 847-288-7031
• Email: ggeary@delmedical.com
• Phone: 847-288-7031
• Email: ggeary@delmedical.com
• Phone: 847-288-7031
• Email: ggeary@delmedical.com
• Phone: 847-288-7031
• Email: ggeary@delmedical.com
• Phone: 847-288-7031
• Email: ggeary@delmedical.com
• Phone: 847-288-7031
• Email: ggeary@delmedical.com
• Phone: 847-288-7031
• Email: ggeary@delmedical.com
• Phone: 847-288-7031
• Email: ggeary@delmedical.com
• Phone: 847-288-7031
• Email: ggeary@delmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858340006004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173018

FDA Product Code

• IZL: System, X-Ray, Mobile

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-08-19
• Device Publish Date: 2019-08-09

On-Brand Devices [Del Medical]

• 00858340006004: This a motorized mobile diagnostic x-ray system. The Mobile Direct Radiographic system facilitat
• 00858340006387: The VS50 is a wall-mounted long-length imaging radiographic cassette holder. This device is a su