| Primary Device ID | 06975132956072 |
| NIH Device Record Key | 90b6f9dd-7ae1-4579-b07f-cbed413d66e9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Eighteeth |
| Version Model Number | ibG3035S |
| Company DUNS | 560366787 |
| Company Name | Changzhou Sifary Medical Technology Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 06975132956072 [Primary] |
| FSP | Loupe, Diagnostic/Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-02 |
| Device Publish Date | 2024-03-25 |
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 |