Catalog Number

-

Brand Name

Mammotome MicroMark II

Version/Model Number

C1540

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

K020276,K020276

Product Code

NEU

Product Code Name

Marker, Radiographic, Implantable

Public Device Record Key

6679387b-f952-43f1-8568-eb64aa36869f

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

December 13, 2016

Package DI Number

10841911100390

Quantity per Package

5

Contains DI Package

00841911100393

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-