GXDP-700 900567

GUDID 06430035872114

PaloDEx Group Oy

Limited-view-field CT system
Primary Device ID06430035872114
NIH Device Record Keyb8556109-9544-4a73-bb7f-af1eb1be8b3d
Commercial Distribution StatusIn Commercial Distribution
Brand NameGXDP-700
Version Model NumberGXDP-700-1
Catalog Number900567
Company DUNS459955188
Company NamePaloDEx Group Oy
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

Customer Support Contacts

Phone8005586120
Emailkkg.imaging@kavokerrgroup.com

Device Identifiers

Device Issuing AgencyDevice ID
GS106430035872114 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OASX-Ray, Tomography, Computed, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-31

On-Brand Devices [GXDP-700]

06430035872145GXDP-700-1
06430035872138GXDP-700-1
06430035872121GXDP-700-1
06430035872114GXDP-700-1

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