Duns Number:093357739
Device Description: Vu-E, QUAD, TRIO SURG LIGHT, W/MON ARM
Catalog Number
-
Brand Name
Vu
Version/Model Number
NVSD3D3D3M1-E
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K100388,K100388
Product Code
FST
Product Code Name
Light, Surgical, Fiberoptic
Public Device Record Key
c9cae05d-321b-43f2-864d-cc771499e77b
Public Version Date
September 19, 2022
Public Version Number
2
DI Record Publish Date
June 11, 2021
Package DI Number
01816835023638
Quantity per Package
1
Contains DI Package
00816835023639
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 112 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 58 |