Cyber Blade

GUDID 18051414960465

Single use morcellator

SIDAM SRL

Tissue morcellation system handpiece, battery-powered Tissue morcellation system handpiece, battery-powered Tissue morcellation system handpiece, battery-powered Tissue morcellation system handpiece, battery-powered Tissue morcellation system handpiece, battery-powered Tissue morcellation system handpiece, battery-powered Tissue morcellation system handpiece, battery-powered Tissue morcellation system handpiece, battery-powered Tissue morcellation system handpiece, battery-powered Tissue morcellation system handpiece, battery-powered Tissue morcellation system handpiece, battery-powered Tissue morcellation system handpiece, battery-powered Tissue morcellation system handpiece, battery-powered Tissue morcellation system handpiece, battery-powered Tissue morcellation system handpiece, battery-powered Tissue morcellation system handpiece, battery-powered

• Primary Device ID: 18051414960465
• NIH Device Record Key: 09aa685b-c98e-49f6-9eed-a51d7fbfd1ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cyber Blade
• Version Model Number: 20041001
• Company DUNS: 443780226
• Company Name: SIDAM SRL
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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	08051414960468 [Primary]
GS1	18051414960465 [Package]; Contains: 08051414960468; Package: carton box [5 Units]; In Commercial Distribution
GS1	28051414960462 [Package]; Package: carton box [4 Units]; In Commercial Distribution

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]

• 08051414960482: Cyber Blade charging station for Cyber Blade motor
• 08051414960475: Battery powered Motor for Cyber Blade morcellator
• 18051414960465: Single use morcellator