CyberWand Probe Set

GUDID 00855279005009

CYBERSONICS INC

Ultrasonic lithotripsy system handpiece

• Primary Device ID: 00855279005009
• NIH Device Record Key: 6bc2e668-f4a9-4c9a-b2cd-3d237741cc1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CyberWand Probe Set
• Version Model Number: CW-RBP
• Company DUNS: 943561522
• Company Name: CYBERSONICS INC
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855279005009 [Primary]
GS1	10855279005006 [Package]; Package: [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120303

FDA Product Code

• FFK: Lithotriptor, Electro-Hydraulic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-31

On-Brand Devices [CyberWand Probe Set]

• 00855279005009: CW-RBP
• H891CWRBPBX3: CW-RBP