EHL Probe

GUDID 06973204210794

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

Electrohydraulic lithotripsy system
Primary Device ID06973204210794
NIH Device Record Key30227e3c-2923-4af1-b980-900498d2478c
Commercial Distribution StatusIn Commercial Distribution
Brand NameEHL Probe
Version Model NumberSCDG - BS
Company DUNS540482563
Company NameGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106973204210794 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FFKLithotriptor, Electro-Hydraulic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[06973204210794]

Ethylene Oxide


[06973204210794]

Ethylene Oxide


[06973204210794]

Ethylene Oxide


[06973204210794]

Ethylene Oxide


[06973204210794]

Ethylene Oxide


[06973204210794]

Ethylene Oxide


[06973204210794]

Ethylene Oxide


[06973204210794]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-04
Device Publish Date2025-06-26

On-Brand Devices [EHL Probe]

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

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