Catalog Number

-

Brand Name

Mammotome HydroMARK

Version/Model Number

4010-05-10-T1

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

K203097,K203097

Product Code

NEU

Product Code Name

Marker, Radiographic, Implantable

Public Device Record Key

ae202247-9f40-49fe-99eb-6bba3a6a5e24

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

March 02, 2022

Package DI Number

10841911102424

Quantity per Package

10

Contains DI Package

00841911102427

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-