Duns Number:556373053
Device Description: The Vividimage 31-inch 4K Surgical Display, Generator 2, without power is designed for th The Vividimage 31-inch 4K Surgical Display, Generator 2, without power is designed for the most demanding surgical environments through its delivery of realistic color accuracy, improved visualization of fine structure details, and enhanced depth perception.
Catalog Number
RLM314KNPWR
Brand Name
Vividimage 4K
Version/Model Number
RLM314KNPWR
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KQM
Product Code Name
CAMERA, SURGICAL AND ACCESSORIES
Public Device Record Key
47a36af7-e51a-48b0-af17-2d80cc2b57e2
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
March 31, 2021
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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |