Primary Device ID | G465FG13140 |
NIH Device Record Key | e54570e6-e19a-497a-a06c-4d4ae242b15e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | View4SurgN |
Version Model Number | FG1314 |
Company DUNS | 115617378 |
Company Name | Smartsurgn Inc. |
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 | false |
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 | G465FG13140 [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 | 2023-10-30 |
Device Publish Date | 2023-10-20 |
G465FG13240 - Light Cable | 2024-07-25 Schott Fiber Optic Light Cable |
G465FG11220 - OptIcSurgN | 2024-02-07 OptIcRSurgN 10mm ICG Laparoscope 0° |
G465FG11230 - OptIcSurgN | 2024-02-07 OptIcRSurgN 10mm ICG Laparoscope 30° |
E30000019 - EyeRSurgN | 2023-11-28 EyeRSurgN Camera System |
G465FG13140 - View4SurgN | 2023-10-3032" 4K Monitor |
G465FG13140 - View4SurgN | 2023-10-30 32" 4K Monitor |
G465100100 - EyeRSurgN | 2023-10-24 4K 4-Chip Camera Console |
G465100200 - IRLightSurgN | 2023-10-24 LED & Laser Light Source |
G465100400 - PrizMCurgN | 2023-10-24 4K 4-Chip Camera Head |