SPORTARREDO

GUDID 08030389004643

SPORTARREDO GROUP S.C.

Ultraviolet tanning device

• Primary Device ID: 08030389004643
• NIH Device Record Key: 5d2b08b0-9d1f-42e2-9a55-8b87045dde49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPORTARREDO
• Version Model Number: LP2 USA
• Company DUNS: 435527116
• Company Name: SPORTARREDO GROUP S.C.
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	08030389004643 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161394

FDA Product Code

• LEJ: Booth, Sun Tan

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: 2020-07-30
• Device Publish Date: 2020-07-22

On-Brand Devices [SPORTARREDO]

• 08030389004704: MASTERSUN 360 USA
• 08030389004681: HPO USA
• 08030389004667: VEGA LUX USA
• 08030389004650: LP3 USA
• 08030389004643: LP2 USA
• 08030389004636: LP1 USA
• 08030389004698: BPHASE USA