Catalog Number

WFN-2020

Brand Name

Westcott Needle

Version/Model Number

WFN-2020

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

K980122,K980122

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

473ca806-ecf0-4006-8f25-7cdab8d7297a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

20886333220100

Quantity per Package

10

Contains DI Package

00886333220106

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box