StarX PRO-2

GUDID E31593800012000

FONA SRL

Dental digital imaging sensor, intraoral
Primary Device IDE31593800012000
NIH Device Record Key9af1866d-5284-4146-8813-13ccbdc15e7c
Commercial Distribution StatusIn Commercial Distribution
Brand NameStarX PRO-2
Version Model Number9380001200
Company DUNS514320345
Company NameFONA SRL
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
HIBCCE31593800012000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUHSystem, X-Ray, Extraoral Source, Digital

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-10
Device Publish Date2021-09-02

Devices Manufactured by FONA SRL

E3158468260320 - FONA ART Plus2023-06-20
E3158468463121 - FONA ART Plus C2023-06-20
E3158468463221 - FONA ART Plus C2023-06-20
E3159319001700 - FONA XDC2022-09-14
E3158468600000 - Stellaris 3D2022-05-09
E3158468600002 - Stellaris 3D Ceph2022-05-09
E3158468600007 - Stellaris 2D2022-05-09
E3158468600008 - Stellaris 2D Ceph2022-05-09

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