EHL Probe

GUDID 06973204210800

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

Electrohydraulic lithotripsy system

• Primary Device ID: 06973204210800
• NIH Device Record Key: a95c7f5c-30c3-420a-a676-2c87421fa77f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EHL Probe
• Version Model Number: SCDG - CS
• 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: true
• 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	06973204210800 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243032

FDA Product Code

• FFK: Lithotriptor, Electro-Hydraulic

Sterilization

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

[06973204210800]

Ethylene Oxide

[06973204210800]

Ethylene Oxide

[06973204210800]

Ethylene Oxide

[06973204210800]

Ethylene Oxide

[06973204210800]

Ethylene Oxide

[06973204210800]

Ethylene Oxide

[06973204210800]

Ethylene Oxide

[06973204210800]

Ethylene Oxide

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

On-Brand Devices [EHL Probe]

• 06973204210800: SCDG - CS
• 06973204210794: SCDG - BS
• 06973204210787: SCDG - AS