Catalog Number

MLX2015

Brand Name

MAMMOREP LOOP MLX

Version/Model Number

MAMMOREP LOOP MLX

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

K051506,K051506

Product Code

FCG

Product Code Name

Biopsy Needle

Public Device Record Key

08656505-e7b9-4c79-a345-143e75dc5e43

Public Version Date

October 11, 2019

Public Version Number

1

DI Record Publish Date

October 03, 2019

Package DI Number

18033959221898

Quantity per Package

10

Contains DI Package

08033959221891

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-