Catalog Number

-

Brand Name

Mammotome revolve mammomark

Version/Model Number

MMK1001

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

K082278,K082278

Product Code

FZP

Product Code Name

Clip, Implantable

Public Device Record Key

f54650b1-d9a7-43d9-9c30-4666578a16ff

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

November 17, 2016

Package DI Number

10841911101632

Quantity per Package

10

Contains DI Package

00841911101635

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-