VS3 Iridium 153-0073
GUDID 10813040013636
VS3 Iridium Endoscope-IR 10mm, Long, 0°, Standard FOV
VISIONSENSE LTD.
Endoscope video camera| Primary Device ID | 10813040013636 |
| NIH Device Record Key | 4f531e96-ffe9-402c-a8d3-16a9441fd7ea |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VS3 Iridium |
| Version Model Number | VS3-IR |
| Catalog Number | 153-0073 |
| Company DUNS | 532199478 |
| Company Name | VISIONSENSE 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 | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10813040013636 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K152204
FDA Product Code
| GCJ | Laparoscope, General & Plastic Surgery |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[10813040013636]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-07-13 |
| Device Publish Date | 2019-08-07 |
On-Brand Devices [VS3 Iridium ]
| 10813040013261 | VS3 Iridium Endoscope-IR 10mm, Long, 0°, Standard FOV - Refurbished |
| 10813040013254 | VS3 Iridium Endoscope-IR 5.5 mm, 0°, Standard View - Refurbished |
| 10813040013858 | VS3 Iridium Endoscope-IR 5.5 mm, 0°, Standard View |
| 10813040013636 | VS3 Iridium Endoscope-IR 10mm, Long, 0°, Standard FOV |
| 10884521844698 | VS3 Iridium - Laser Light Source, 785nm (LLS) |
| 10884521844681 | VS3 Iridium - Miniature Microscope, 785nm (MMS-IR) |
| 10884521815926 | VS3 Iridium - Fluorescence High Definition Camera, 785nm (Camera-IR) |
Trademark Results [VS3 Iridium]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VS3 IRIDIUM 79170004 4916070 Live/Registered |
Visionsense Ltd. 2015-04-19 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.