Cyber Blade

GUDID 08059173391707

Cyber Blade Morcelletor Set

QUANTA SYSTEM SPA

Tissue morcellation system handpiece, battery-powered

• Primary Device ID: 08059173391707
• NIH Device Record Key: a4723890-d1cc-4a34-89c6-25f3fd4e06b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cyber Blade
• Version Model Number: CVA000002
• 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: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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	08059173391707 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192499

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-12
• Device Publish Date: 2021-02-04

On-Brand Devices [Cyber Blade]

• 08059173391707: Cyber Blade Morcelletor Set
• 08059173391691: Cyber Blade Starting Kit