Twain Evo

GUDID 08059173391851

Intense Pulsed Light handpiece 590 nm 48x13 (cooled)

QUANTA SYSTEM SPA

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• Primary Device ID: 08059173391851
• NIH Device Record Key: edb8f5a6-005e-4c78-8b3d-fb8a9274c1f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Twain Evo
• Version Model Number: OAM001834.01
• 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	08059173391851 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192160

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: 2021-10-13
• Device Publish Date: 2021-10-05

On-Brand Devices [Twain Evo]

• 08033945935153: Intense Pulsed Light handpiece 590 nm 48x13 (cooled)
• 08033945935092: Intense Pulsed Light handpiece 625 nm 48x13
• 08033945935078: Intense Pulsed Light handpiece 590 nm 48x13
• 08033945935047: Intense Pulsed Light handpiece 550 nm 25x13
• 08059173391851: Intense Pulsed Light handpiece 590 nm 48x13 (cooled)