GUDID 00198953023266

G3A standard Wallstand

GE Hualun Medical Systems Co., Ltd

Stationary basic diagnostic x-ray system, digital
Primary Device ID00198953023266
NIH Device Record Keyce1a8b7f-878f-4ba8-b935-f686eed48508
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberGCWS-C3
Company DUNS554408665
Company NameGE Hualun Medical Systems Co., Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100198953023266 [Primary]

FDA Product Code

IXYHolder, Radiographic Cassette, Wall-Mounted

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-10
Device Publish Date2025-02-28

Devices Manufactured by GE Hualun Medical Systems Co., Ltd

00198953023259 - NA2025-03-10 G4 Non-Tilting Wallstand
00198953023266 - NA2025-03-10G3A standard Wallstand
00198953023266 - NA2025-03-10 G3A standard Wallstand

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