Catalog Number

-

Brand Name

Mammotome

Version/Model Number

MHH8

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

K003297,K003297

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

cf132ed1-cdd4-446e-8939-99001cafe5f1

Public Version Date

July 12, 2019

Public Version Number

4

DI Record Publish Date

October 24, 2016

Package DI Number

10841911100994

Quantity per Package

5

Contains DI Package

00841911100997

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-