Radmedix

GUDID 00810035220072

RADMEDIX, LLC

Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 00810035220072
• NIH Device Record Key: 5158108b-2384-4c52-a7b9-9205fb60529c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Radmedix
• Version Model Number: AcuitySDR+
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810035220072 [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

[00810035220072]

Liquid Chemical

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-06
• Device Publish Date: 2020-02-27

On-Brand Devices [Radmedix]

• 00810035220102: AcuitySDR
• 00810035220096: AcuitySDR
• 00810035220089: AcuitySDR+
• 00810035220072: AcuitySDR+
• 00810035220065: AcuitySDR+