FXRD-1717N

GUDID 08809394330210

VIEWORKS CO., LTD.

Indirect flat panel x-ray detector
Primary Device ID08809394330210
NIH Device Record Keyc3f5928e-9643-42f1-86cd-e0e25b38ca5a
Commercial Distribution Discontinuation2020-01-01
Commercial Distribution StatusIn Commercial Distribution
Brand NameFXRD-1717N
Version Model NumberFXRD-1717NBW
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 Usetrue
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
GS108809394330210 [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 StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-05-07
Device Publish Date2016-07-15

On-Brand Devices [FXRD-1717N]

08809394330210FXRD-1717NBW
08809394330203FXRD-1717NAW
08809394330197FXRD-1717NB
08809394330180FXRD-1717NA

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