Catalog Number

-

Brand Name

Mammotome

Version/Model Number

G020F

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)

Yes

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

K943863,K943863

Product Code

IYN

Product Code Name

System, Imaging, Pulsed Doppler, Ultrasonic

Public Device Record Key

9f48e14a-84e5-4d49-bd93-92d2a327c298

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

February 04, 2022

Package DI Number

10841911101175

Quantity per Package

25

Contains DI Package

00841911101178

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-