Catalog Number

VCS1815EX

Brand Name

VCS

Version/Model Number

VCS

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

K051506,K051506

Product Code

FCG

Product Code Name

Biopsy Needle

Public Device Record Key

774b9e7f-ab91-49a2-b11b-595c3e6fe67a

Public Version Date

October 11, 2019

Public Version Number

1

DI Record Publish Date

October 03, 2019

Package DI Number

18033959228040

Quantity per Package

20

Contains DI Package

08033959228043

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-