Orthopantomograph OP 3D 901085

GUDID 06430035873630

PaloDEx Group Oy

Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system
Primary Device ID06430035873630
NIH Device Record Keycc8ca86f-23fc-45f3-b977-d53d55a26cdc
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrthopantomograph OP 3D
Version Model Number3D upgrade kit for OP 3D
Catalog Number901085
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106430035873630 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-08
Device Publish Date2021-05-31

On-Brand Devices [Orthopantomograph OP 3D]

06430035872879ORTHOPANTOMOGRAPH OP 3D (pan)
06430035872862ORTHOPANTOMOGRAPH OP 3D cranio-maxillofacial xray device for panoramic, cephalometric and cbct i
06430035872688ORTHOPANTOMOGRAPH OP 3D (pan/cbct)
06430035872886ORTHOPANTOMOGRAPH OP 3D (pan/ceph)
064300358736303D upgrade kit for OP 3D
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