Quanta forte

GUDID 08033945934668

QUANTA SYSTEM SPA

Multi-modality skin surface treatment system generator

• Primary Device ID: 08033945934668
• NIH Device Record Key: c94e8d83-a35c-4899-892d-c2aea6af7f60
• Commercial Distribution Discontinuation: 2018-11-16
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Quanta forte
• Version Model Number: PZMS00012
• 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	08033945934668 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152714

FDA Product Code

• ONF: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-07-01
• Device Publish Date: 2016-08-18

On-Brand Devices [Quanta forte]

• 08033945934750: PZMS00013
• 08033945934668: PZMS00012
• 08033945934651: PZMS00011