Catalog Number

-

Brand Name

Mammotome revolve

Version/Model Number

MST1012

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

K152989,K152989

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

7485c173-5857-4856-86ef-412fe1a10de3

Public Version Date

February 16, 2022

Public Version Number

1

DI Record Publish Date

February 08, 2022

Package DI Number

10841911102608

Quantity per Package

5

Contains DI Package

00841911102601

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-