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 ID: 08809840720015
• NIH Device Record Key: f79696fb-3179-4dee-ae69-6c5a63ef9e6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WeSensor
• Version Model Number: F350A
• Company DUNS: 694616916
• Company Name: PICOPACK Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809840720015 [Primary]
GS1	18809840720012 [Package]; Package: Cardboard [5 Units]; In Commercial Distribution
GS1	28809840720019 [Package]; Package: Cardboard [10 Units]; In Commercial Distribution
GS1	38809840720016 [Package]; Package: Cardboard [20 Units]; In Commercial Distribution
GS1	48809840720013 [Package]; Package: Cardboard [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230916

FDA Product Code

• MUH: System, X-Ray, Extraoral Source, Digital

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-05
• Device Publish Date: 2023-11-27

On-Brand Devices [WeSensor]

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