WeSensor

GUDID 08809840720039

The WeSensor is an intraoral digital x-ray sensor. This model uses a scintillator made from Gadolinium Oxysulfide (Gd2O2S:Tb), and there is no filter layer in these models. The dimension of this sensor is 37.0 mm × 27.0 mm× 10.0 mm.

PICOPACK Inc.

Dental digital imaging sensor, intraoral
Primary Device ID08809840720039
NIH Device Record Keyb5bc6467-7ccf-4f1f-b2f1-f201f8e442f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameWeSensor
Version Model NumberG150A
Company DUNS694616916
Company NamePICOPACK Inc.
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

Device Identifiers

Device Issuing AgencyDevice ID
GS108809840720039 [Primary]
GS118809840720036 [Package]
Package: Cardboard [5 Units]
In Commercial Distribution
GS128809840720033 [Package]
Package: Cardboard [10 Units]
In Commercial Distribution
GS138809840720030 [Package]
Package: Cardboard [20 Units]
In Commercial Distribution
GS148809840720037 [Package]
Package: Cardboard [50 Units]
In Commercial Distribution

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 Date2023-12-05
Device Publish Date2023-11-27

On-Brand Devices [WeSensor]

08809840720039The WeSensor is an intraoral digital x-ray sensor. This model uses a scintillator made from Gado
08809840720022The WeSensor is an intraoral digital x-ray sensor. This model uses a scintillator made from Thal
08809840720015The WeSensor is an intraoral digital x-ray sensor. This model uses a scintillator made from Thal
08809840720008The WeSensor is an intraoral digital x-ray sensor. This model uses a scintillator made from Gado

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