VIVIX-S FW

GUDID 08809394330609

VIEWORKS CO., LTD.

Indirect flat panel x-ray detector
Primary Device ID08809394330609
NIH Device Record Key65d81586-242c-471b-a341-b33d47a00141
Commercial Distribution StatusIn Commercial Distribution
Brand NameVIVIX-S FW
Version Model NumberFXRD-4343FAW
Company DUNS688274778
Company NameVIEWORKS 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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809394330609 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-23
Device Publish Date2023-10-13

On-Brand Devices [VIVIX-S FW]

08809394330609FXRD-4343FAW
08809394330593FXRD-3643FAW
08809394330586FXRD-2530FAW

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