RadiaLux™

GUDID 00763000280055

RETRACTOR 50-101-1 RADIALUX US

MEDTRONIC NAVIGATION, INC.

Self-retaining surgical retractor, single-use

• Primary Device ID: 00763000280055
• NIH Device Record Key: ca4e4212-9cdf-49cd-83d6-4986288ee312
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RadiaLux™
• Version Model Number: 50-101-1
• Company DUNS: 835233107
• Company Name: MEDTRONIC NAVIGATION, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000280055 [Primary]

FDA Product Code

• GAD: RETRACTOR

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-23
• Device Publish Date: 2020-03-15

On-Brand Devices [RadiaLux™]

• 00763000280062: RETRACTOR 50-101-1 RADIALUX US PINK
• 00763000280055: RETRACTOR 50-101-1 RADIALUX US
• 00763000432805: RETRACTOR 50-101-1 RADIALUX CE PINK
• 00763000432799: RETRACTOR 50-101-1 RADIALUX CE