Catalog Number

-

Brand Name

Fullcore Biopsy Needle

Version/Model Number

DNG-2020-16-0250

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

-

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

021e57ba-9e05-4374-9614-e551c8c30d6d

Public Version Date

February 07, 2022

Public Version Number

4

DI Record Publish Date

August 26, 2018

Package DI Number

04260277178086

Quantity per Package

10

Contains DI Package

04260277178079

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-