Radmedix AcuityUDR

GUDID 00810035220454

RADMEDIX, LLC

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

• Primary Device ID: 00810035220454
• NIH Device Record Key: d5e41174-f375-40c2-82e7-d1d840fda296
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Radmedix AcuityUDR
• Version Model Number: 1
• Company DUNS: 005057263
• Company Name: RADMEDIX, LLC
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810035220454 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193360

FDA Product Code

• KPR: System, X-Ray, Stationary

Sterilization

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

[00810035220454]

Liquid Chemical

[00810035220454]

Liquid Chemical

[00810035220454]

Liquid Chemical

[00810035220454]

Liquid Chemical

[00810035220454]

Liquid Chemical

[00810035220454]

Liquid Chemical

[00810035220454]

Liquid Chemical

[00810035220454]

Liquid Chemical

[00810035220454]

Liquid Chemical

[00810035220454]

Liquid Chemical

[00810035220454]

Liquid Chemical

[00810035220454]

Liquid Chemical

[00810035220454]

Liquid Chemical

[00810035220454]

Liquid Chemical

[00810035220454]

Liquid Chemical

[00810035220454]

Liquid Chemical

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-07
• Device Publish Date: 2021-11-29

On-Brand Devices [Radmedix AcuityUDR]

• 00810035220454: 1
• 00810035220522: RadmediX AcuityUDR combines components into a complete stationary x-ray system, including tube s