FDA UDI
In Commercial Distribution
🇺🇸 United States
WeSensor
DI: 08809840720008
·
Model: G350A
·
PICOPACK Inc.
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- WeSensor
- Primary DI
- 08809840720008
- Version / Model
- G350A
- 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
- 343cc3cf-4e12-4cd0-9705-5281ea8fa91d
Device Description
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.
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 | 08809840720008 | GS1 | ||||
| Package | 18809840720005 | GS1 | Cardboard | 5 | In Commercial Distribution | |
| Package | 28809840720002 | GS1 | Cardboard | 10 | In Commercial Distribution | |
| Package | 38809840720009 | GS1 | Cardboard | 20 | In Commercial Distribution | |
| Package | 48809840720006 | GS1 | Cardboard | 50 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230916 | 000 |