Catalog Number

MK2011

Brand Name

Gel Mark Ultra™ Breast Tissue Marker

Version/Model Number

MK2011

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"

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

K011402,K011402

Product Code

FZP

Product Code Name

CLIP, IMPLANTABLE

Public Device Record Key

9584c65e-3d3f-4ae3-a8dd-d195c3ee275f

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

October 01, 2015

Package DI Number

10801741031882

Quantity per Package

10

Contains DI Package

00801741031885

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA