Catalog Number

5710

Brand Name

VELscope

Version/Model Number

VELcap 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,K102083

Product Code

NXV

Product Code Name

Diagnostic Light, Soft Tissue Detector

Public Device Record Key

18139c60-66ae-4fc8-a03d-c4f5365ac249

Public Version Date

November 10, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

17540201000022

Quantity per Package

16

Contains DI Package

07540201000025

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Dispenser Box-16