Lithotripsy Probe, Sterile Single Use ShockPulse -SE, 5.5 Fr (1.83mm) X 418mm

GUDID 00855279005139

CYBERSONICS INC

Ultrasonic lithotripsy system handpiece

• Primary Device ID: 00855279005139
• NIH Device Record Key: e2d52211-de5f-4460-8d81-9ac6d3d50fb9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lithotripsy Probe, Sterile Single Use ShockPulse -SE, 5.5 Fr (1.83mm) X 418mm
• Version Model Number: SPL-PD183
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855279005139 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142428

FDA Product Code

• FEO: Lithotriptor, Ultrasonic

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: 2016-04-30

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