Medical X-ray High Frequency High Voltage Generator

GUDID 06973858210492

Suzhou Powersite Electric Co., LTD

Diagnostic x-ray system generator, stationary
Primary Device ID06973858210492
NIH Device Record Key57609517-c1b1-4d2f-b0c5-b26c7465e0d5
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedical X-ray High Frequency High Voltage Generator
Version Model NumberPSG-HR80S5
Company DUNS543889068
Company NameSuzhou Powersite Electric Co., LTD
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106973858210492 [Primary]

FDA Product Code

IZOGenerator, High-Voltage, X-Ray, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-06
Device Publish Date2025-05-29

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