Catalog Number

-

Brand Name

Mammotome CORMARK

Version/Model Number

MAM3014

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

K082278,K082278

Product Code

FZP

Product Code Name

Clip, Implantable

Public Device Record Key

a324800d-90b0-412c-84f9-7a776396e8ce

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

November 17, 2016

Package DI Number

10841911100451

Quantity per Package

10

Contains DI Package

00841911100454

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-