Catalog Number

5720

Brand Name

VELscope

Version/Model Number

VELsheath Vx

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

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

K102083,K102083,K102083

Product Code

NXV

Product Code Name

Diagnostic Light, Soft Tissue Detector

Public Device Record Key

e4c642fe-e266-43f9-9c36-45ebceae9dee

Public Version Date

December 06, 2019

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

27540201000036

Quantity per Package

12

Contains DI Package

17540201000039

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton-3000