CyberWand USL Advanced Transducer

GUDID 00855279005320

CYBERSONICS INC

Pneumatic/ultrasonic lithotripsy system

• Primary Device ID: 00855279005320
• NIH Device Record Key: a113d94e-4da6-4195-9c98-451f70267290
• 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
GS1	00855279005320 [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

[00855279005320]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00855279005320]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00855279005320]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00855279005320]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00855279005320]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00855279005320]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00855279005320]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00855279005320]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00855279005320]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00855279005320]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00855279005320]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00855279005320]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00855279005320]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00855279005320]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00855279005320]

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: 2016-08-31

On-Brand Devices [CyberWand USL Advanced Transducer]

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