Catalog Number

-

Brand Name

Biopsy Handy

Version/Model Number

900146

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 30, 2020

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

-

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

6d781c50-868e-48fe-85a3-c82b1fa50796

Public Version Date

October 27, 2021

Public Version Number

5

DI Record Publish Date

October 11, 2016

Package DI Number

04250195606228

Quantity per Package

10

Contains DI Package

04250195601957

Package Discontinue Date

July 30, 2020

Package Status

Not in Commercial Distribution

Package Type

-