CyberWand USL Advanced Transducer

GUDID H891CWUSLTA2

CYBERSONICS INC

Pneumatic/ultrasonic lithotripsy system

• Primary Device ID: H891CWUSLTA2
• NIH Device Record Key: fb9d9032-4f89-454c-b2b3-573ec18e2c7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CyberWand USL Advanced Transducer
• Version Model Number: CW-USLTA
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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
HIBCC	H891CWUSLTA2 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120303

FDA Product Code

• FFK: Lithotriptor, Electro-Hydraulic

Sterilization

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

[H891CWUSLTA2]

Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-05-23

On-Brand Devices [CyberWand USL Advanced Transducer]

• 00855279005320: CW-USLTA
• H891CWUSLTA2: CW-USLTA