Eighteeth
GUDID 06941877803193
The HyperLight Hand-held Dental X-ray System is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors. This device must only be used in hospital environments, clinics or dental offices where appropriate safeguards are implemented, and not used in the oxygen-rich environment.
Changzhou Sifary Medical Technology Co., Ltd.
Hand-held intraoral dental x-ray system, digital| Primary Device ID | 06941877803193 |
| NIH Device Record Key | 093965eb-de94-42a3-b3c6-339751982444 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Eighteeth |
| Version Model Number | HyperLight |
| 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 | 06941877803193 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K232068
FDA Product Code
| EHD | Unit, X-Ray, Extraoral With Timer |
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 | 2024-04-03 |
| Device Publish Date | 2024-03-26 |
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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