RADII 5600102

GUDID DO3656001021

SDI LIMITED

Dental/surgical polymerization lamp

• Primary Device ID: DO3656001021
• NIH Device Record Key: 3d2dc519-eab7-445a-ba05-2d60becd5092
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RADII
• Version Model Number: RADII-CAL LED LGT ALL REG
• Catalog Number: 5600102
• Company DUNS: 753221852
• Company Name: SDI LIMITED
• 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: true
• 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: +18002285166
• Email: info@sdi.com.au

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	DO3656001021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030568

FDA Product Code

• EBZ: ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-26

On-Brand Devices [RADII]

• DO3656002021: RADII PLUS LED LGT ALL REG
• DO3656001021: RADII-CAL LED LGT ALL REG