Primary Device ID | G465100100 |
NIH Device Record Key | fe9823cc-8ae2-4fc4-ad79-53497275a153 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | EyeRSurgN |
Version Model Number | 10010 |
Company DUNS | 115617378 |
Company Name | Smartsurgn Inc. |
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 | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | G465100100 [Primary] |
OWN | Confocal Optical Imaging |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-10-24 |
Device Publish Date | 2023-10-16 |
G465100100 | 4K 4-Chip Camera Console |
E30000019 | EyeRSurgN Camera System |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
EYERSURGN 88898552 not registered Live/Pending |
SmartSurgN Inc. 2020-05-03 |