Catalog Number

-

Brand Name

Mammotome elite

Version/Model Number

MEI10

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

K153709,K153709

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

d29090c0-3bac-408b-9bce-24abe7921145

Public Version Date

February 14, 2022

Public Version Number

1

DI Record Publish Date

February 04, 2022

Package DI Number

10841911100864

Quantity per Package

5

Contains DI Package

00841911100867

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-