Extracorporeal Shock Wave Lithotripter

GUDID 06975438931018

Suzhou Xixin Medical Instruments Co., Ltd.

Electromechanical lithotripsy system, extracorporeal

• Primary Device ID: 06975438931018
• NIH Device Record Key: 082c2134-e305-4cef-9150-1647c4b76603
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Extracorporeal Shock Wave Lithotripter
• Version Model Number: CS-2012A-3
• Company DUNS: 527113190
• Company Name: Suzhou Xixin Medical Instruments Co., Ltd.
• 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975438931018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131817

FDA Product Code

• LNS: Lithotriptor, Extracorporeal Shock-Wave, Urological

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-02
• Device Publish Date: 2023-12-25