Lithotripsy System ShockPulse-SE

GUDID 00855279005016

CYBERSONICS INC

Pneumatic/ultrasonic lithotripsy system

• Primary Device ID: 00855279005016
• NIH Device Record Key: b10ab31c-ced6-4209-a98d-9956f4beeb61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lithotripsy System ShockPulse-SE
• Version Model Number: SPL-S
• 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: true
• 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	00855279005016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142428

FDA Product Code

• FEO: Lithotriptor, Ultrasonic

Sterilization

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

[00855279005016]

Moist Heat or Steam Sterilization

[00855279005016]

Moist Heat or Steam Sterilization

[00855279005016]

Moist Heat or Steam Sterilization

[00855279005016]

Moist Heat or Steam Sterilization

[00855279005016]

Moist Heat or Steam Sterilization

[00855279005016]

Moist Heat or Steam Sterilization

[00855279005016]

Moist Heat or Steam Sterilization

[00855279005016]

Moist Heat or Steam Sterilization

[00855279005016]

Moist Heat or Steam Sterilization

[00855279005016]

Moist Heat or Steam Sterilization

[00855279005016]

Moist Heat or Steam Sterilization

[00855279005016]

Moist Heat or Steam Sterilization

[00855279005016]

Moist Heat or Steam Sterilization

[00855279005016]

Moist Heat or Steam Sterilization

[00855279005016]

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: 2016-04-30

Devices Manufactured by CYBERSONICS INC

• H891CWRBPBX3 - CyberWand Probe Set: 2018-07-06
• H891CWUSLFS2 - CyberWand USL Foot Switch: 2018-07-06
• H891CWUSLG2 - CyberWand USL Generator: 2018-07-06
• H891CWUSLNC2 - CyberWand USL NoseCone Kit: 2018-07-06
• H891CWUSLPC2 - CyberWand USL Power Cord: 2018-07-06
• H891CWUSLSA4 - CyberWand USL Ultrasonic Lithotripsy System: 2018-07-06
• H891CWUSLTA2 - CyberWand USL Advanced Transducer: 2018-07-06
• H891CWUSLW2 - Cyberwand USL Wrench: 2018-07-06