Duns Number:828549936
Device Description: The SurgiLight by View Medical is a surgical lighting system that aims to provide surgeons The SurgiLight by View Medical is a surgical lighting system that aims to provide surgeons with a safe and practical illumination device to focus on specific target areas. It mounts to the handle attachment anchor point of various overhead surgical lights, and features a long, flexible shaft that will allow the user to direct the light onto the incision from any desired angle. The View Medical SurgiLight shall be used in conjunction with the sterile Disposable Handle Assembly.
Catalog Number
-
Brand Name
View Medical SurgiLight
Version/Model Number
2816-01-0001
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FTA
Product Code Name
Light, Surgical, Accessories
Public Device Record Key
877370e1-8b3a-4848-af50-b5ec7beee8f0
Public Version Date
January 08, 2021
Public Version Number
2
DI Record Publish Date
August 05, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |