Primary Device ID | 06975132955938 |
NIH Device Record Key | 524637d6-cd0e-4a72-86df-39471a6de2df |
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 | 06975132955938 [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 |