FDA UDI
In Commercial Distribution
🇺🇸 United States
WeSensor
DI: 08809840720015
·
Model: F350A
·
PICOPACK Inc.
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- WeSensor
- Primary DI
- 08809840720015
- Version / Model
- F350A
- Company Name
- PICOPACK Inc.
- Labeler DUNS
- 694616916
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-27
- Public Version
- 1
- Public Version Date
- 2023-12-05
- Public Version Status
- New
- Public Device Record Key
- f79696fb-3179-4dee-ae69-6c5a63ef9e6f
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MUH | System, X-Ray, Extraoral Source, Digital | Dental | 872.1800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44905 | Dental digital imaging sensor, intraoral | An analogue device that is temporarily placed in a patient's mouth to perform routine diagnostic dental imaging procedures. It uses analogue-to-digital conversion techniques to record the absorption pattern of x-ray beams used in the diagnosis and treatment of diseases of the jaw or oral cavity structures. The device is used in combination with the x-ray source (x-ray tube) that is located outside the patient's mouth during the imaging procedure; the resulting digital image is transmitted to a monitor or workstation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809840720015 | GS1 | ||||
| Package | 18809840720012 | GS1 | Cardboard | 5 | In Commercial Distribution | |
| Package | 28809840720019 | GS1 | Cardboard | 10 | In Commercial Distribution | |
| Package | 38809840720016 | GS1 | Cardboard | 20 | In Commercial Distribution | |
| Package | 48809840720013 | GS1 | Cardboard | 50 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230916 | 000 |