Catalog Number

-

Brand Name

Velox Pro

Version/Model Number

VP20160-C0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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"

Yes

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

K092338,K092338

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

27b99cb3-3bfb-4fd5-a7a6-023c81fb9b1d

Public Version Date

June 17, 2022

Public Version Number

7

DI Record Publish Date

September 21, 2016

Package DI Number

18055002900505

Quantity per Package

10

Contains DI Package

08055002900508

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton Box