STARDUST MED

GUDID 08056893740013

Diode laser 808 nm

INTELLIGENCE TARGET SYSTEM SRL

Dermatological laser beam guiding handpiece

• Primary Device ID: 08056893740013
• NIH Device Record Key: aa5f44df-6349-4ed7-a093-3a7a077eb44d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STARDUST MED
• Version Model Number: G100.3000
• Company DUNS: 435742731
• Company Name: INTELLIGENCE TARGET SYSTEM SRL
• 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	08056893740013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200736

FDA Product Code

• GEX: Powered Laser Surgical Instrument

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: 2024-07-04
• Device Publish Date: 2024-06-26