WeSensor

GUDID 08809840720008

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 43.0 mm × 33.0 mm× 12.0 mm.

PICOPACK Inc.

Dental digital imaging sensor, intraoral

• Primary Device ID: 08809840720008
• NIH Device Record Key: 343cc3cf-4e12-4cd0-9705-5281ea8fa91d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WeSensor
• Version Model Number: G350A
• 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	08809840720008 [Primary]
GS1	18809840720005 [Package]; Package: Cardboard [5 Units]; In Commercial Distribution
GS1	28809840720002 [Package]; Package: Cardboard [10 Units]; In Commercial Distribution
GS1	38809840720009 [Package]; Package: Cardboard [20 Units]; In Commercial Distribution
GS1	48809840720006 [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