Electrohydraulic Lithotriptor

GUDID 06973204210763

Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

Electrohydraulic lithotripsy system

• Primary Device ID: 06973204210763
• NIH Device Record Key: 3cb351f5-7da9-4f7e-8dc5-b485e4333d01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Electrohydraulic Lithotriptor
• Version Model Number: TCS-B3-II
• Company DUNS: 540482563
• Company Name: Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• 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	06973204210763 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242888

FDA Product Code

• FFK: Lithotriptor, Electro-Hydraulic

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: 2025-07-04
• Device Publish Date: 2025-06-26

Devices Manufactured by Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

• 06973204210763 - Electrohydraulic Lithotriptor: 2025-07-04
• 06973204210763 - Electrohydraulic Lithotriptor: 2025-07-04
• 06973204210787 - EHL Probe: 2025-07-04
• 06973204210794 - EHL Probe: 2025-07-04
• 06973204210800 - EHL Probe: 2025-07-04