Catalog Number

-

Brand Name

Mammotome MR

Version/Model Number

MRU08X

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K042753,K042753

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

6efb0749-82b1-4bdf-9404-5b5ba5d76f63

Public Version Date

February 07, 2022

Public Version Number

4

DI Record Publish Date

October 25, 2016

Package DI Number

10841911101090

Quantity per Package

1

Contains DI Package

00841911101093

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-