Eighteeth
GUDID 06972597781782
Changzhou Sifary Medical Technology Co., Ltd.
Dental/surgical polymerization lamp| Primary Device ID | 06972597781782 |
| NIH Device Record Key | 3d9143f4-e35b-4cfb-a9bb-f5ba3173dc4a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Eighteeth |
| Version Model Number | CuringPen |
| 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 | 06972597781782 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K221152
FDA Product Code
| EBZ | Activator, Ultraviolet, For Polymerization |
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 | 2024-04-02 |
| Device Publish Date | 2024-03-25 |
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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