FDA UDI
In Commercial Distribution
🇺🇸 United States
Eighteeth
DI: 06941877815196
·
Model: NanoPix1.5
·
Changzhou Sifary Medical Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Eighteeth
- Primary DI
- 06941877815196
- Version / Model
- NanoPix1.5
- Catalog Number
- 6980098
- Company Name
- Changzhou Sifary Medical Technology Co., Ltd.
- Labeler DUNS
- 560366787
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-21
- Public Version
- 1
- Public Version Date
- 2025-01-29
- Public Version Status
- New
- Public Device Record Key
- 73d3bc6e-8e4c-403f-b1d1-a39b198c79f5
Device Description
The NanoPix series sensors (NanoPix1, NanoPix1.5, NanoPix2) are USB-driven digital intraoral sensors based on a CMOS (Complementary Metal Oxide Semiconductor) technology that has been specifically designed for dental applications. The NanoPix series intraoral sensors provide digital diagnostic image capture to replace radiographic film/screen system in general dental diagnostic procedures. The captured digital image is transferred to personal computer via USB port.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 | 06941877815196 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K220422 | 000 |