Duns Number:081712583
Device Description: LIFEVUE 19", WALLMOUNT, W/TOUCH, CUSTOM KARL STORZ US, V3C-SX19-R130
Catalog Number
-
Brand Name
LifeVue
Version/Model Number
90X0531
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 03, 2022
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
Yes
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
KQM
Product Code Name
Camera, Surgical And Accessories
Public Device Record Key
f4db16fb-5a4b-4145-96f7-9892918061d3
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
August 03, 2022
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 | 194 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 147 |