Twain 2940 Evo

GUDID 08033945938314

QUANTA SYSTEM SPA

Dermatological laser beam guiding handpiece

• Primary Device ID: 08033945938314
• NIH Device Record Key: b400750f-da20-4a8a-a186-5d7d48cb015e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Twain 2940 Evo
• Version Model Number: OAM001729
• Company DUNS: 436045833
• Company Name: QUANTA SYSTEM SPA
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033945938314 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173002

FDA Product Code

• GEX: Powered Laser Surgical Instrument

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: 2021-05-24
• Device Publish Date: 2018-03-30

On-Brand Devices [Twain 2940 Evo]

• 08033945938321: OAM002029
• 08033945938314: OAM001729