Duns Number:243167546
Catalog Number
4660
Brand Name
VELscope
Version/Model Number
VELscope Vx Value Bundle-Basic
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
K102083
Product Code
NXV
Product Code Name
Diagnostic Light, Soft Tissue Detector
Public Device Record Key
ac0045e0-ef61-40ef-ba2f-32819740da25
Public Version Date
November 10, 2021
Public Version Number
6
DI Record Publish Date
December 21, 2016
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 10 |