Twain IPL

GUDID 08059173391868

Intense Pulsed Light handpiece 625 nm 48x13 (cooled)

QUANTA SYSTEM SPA

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• Primary Device ID: 08059173391868
• NIH Device Record Key: 678ca51d-c28f-4ad8-ae52-30b8b63ecc3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Twain IPL
• Version Model Number: OAM001836.01
• 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	08059173391868 [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: 2021-01-05
• Device Publish Date: 2020-12-28

On-Brand Devices [Twain IPL]

• 08059173391875: Intense Pulsed Light handpiece 650 nm 48x13 (cooled)
• 08059173391868: Intense Pulsed Light handpiece 625 nm 48x13 (cooled)