WeSensor

GUDID 08809840720015

The WeSensor is an intraoral digital x-ray sensor. This model uses a scintillator made from Thallium-doped Cesium Iodide (CsI:Tl) and Sodium Iodide (NaI:Tl). This model also includes an extra filter layer in the sensor. This unique structure of the scintillator and filter layer further enhances image quality. The dimension of this sensor is 43.0 mm × 33.0 mm× 12.0 mm.

PICOPACK Inc.

Dental digital imaging sensor, intraoral
Primary Device ID08809840720015
NIH Device Record Keyf79696fb-3179-4dee-ae69-6c5a63ef9e6f
Commercial Distribution StatusIn Commercial Distribution
Brand NameWeSensor
Version Model NumberF350A
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
GS108809840720015 [Primary]
GS118809840720012 [Package]
Package: Cardboard [5 Units]
In Commercial Distribution
GS128809840720019 [Package]
Package: Cardboard [10 Units]
In Commercial Distribution
GS138809840720016 [Package]
Package: Cardboard [20 Units]
In Commercial Distribution
GS148809840720013 [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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