Duns Number:542992969
Device Description: The device is a monitor with a 3 inch LCD screen. The device is to be used in conjunction The device is a monitor with a 3 inch LCD screen. The device is to be used in conjunction with various visualization device produced by our company to provide real-time image display.
Catalog Number
-
Brand Name
UE Display
Version/Model Number
VL460
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
CCW
Product Code Name
Laryngoscope, Rigid
Public Device Record Key
caf25b6f-79b2-4329-acaf-a204ba7e2e23
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
September 05, 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 | 1 |