ORTHOPANTOMOGRAPH OP 3D Pro 901004

GUDID 06430035872756

PaloDEx Group Oy

Limited-view-field CT system
Primary Device ID06430035872756
NIH Device Record Key2c70fd6b-f250-4dd2-ac64-56efea57e3fc
Commercial Distribution StatusIn Commercial Distribution
Brand NameORTHOPANTOMOGRAPH OP 3D Pro
Version Model NumberOP300-1
Catalog Number901004
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
GS106430035872756 [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 Date2017-03-31

On-Brand Devices [ORTHOPANTOMOGRAPH OP 3D Pro]

06430035872770OP300-1
06430035872763OP300-1
06430035872756OP300-1
06430035872749OP300-1
06430035872732OP300-1
06430035872725OP300-1

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