Eighteeth 6980098
GUDID 06941877815196
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.
Changzhou Sifary Medical Technology Co., Ltd.
Dental digital imaging sensor, intraoral| Primary Device ID | 06941877815196 |
| NIH Device Record Key | 73d3bc6e-8e4c-403f-b1d1-a39b198c79f5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Eighteeth |
| Version Model Number | NanoPix1.5 |
| Catalog Number | 6980098 |
| Company DUNS | 560366787 |
| Company Name | Changzhou Sifary Medical Technology Co., Ltd. |
| 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 | false |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06941877815196 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K220422
FDA Product Code
| MUH | System, X-Ray, Extraoral Source, Digital |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[06941877815196]
Moist Heat or Steam Sterilization
[06941877815196]
Moist Heat or Steam Sterilization
[06941877815196]
Moist Heat or Steam Sterilization
[06941877815196]
Moist Heat or Steam Sterilization
[06941877815196]
Moist Heat or Steam Sterilization
[06941877815196]
Moist Heat or Steam Sterilization
[06941877815196]
Moist Heat or Steam Sterilization
[06941877815196]
Moist Heat or Steam Sterilization
[06941877815196]
Moist Heat or Steam Sterilization
[06941877815196]
Moist Heat or Steam Sterilization
[06941877815196]
Moist Heat or Steam Sterilization
[06941877815196]
Moist Heat or Steam Sterilization
[06941877815196]
Moist Heat or Steam Sterilization
[06941877815196]
Moist Heat or Steam Sterilization
[06941877815196]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-29 |
| Device Publish Date | 2025-01-21 |
On-Brand Devices [Eighteeth]
Trademark Results [Eighteeth]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EIGHTEETH 79346677 not registered Live/Pending |
Changzhou Sifary Medical Technology Co., Ltd. 2022-06-29 |
 EIGHTEETH 79251962 not registered Dead/Abandoned |
Changzhou Sifary Medical Technology Co., Ltd. 2018-11-23 |
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