Catalog Number

-

Brand Name

NA

Version/Model Number

MEDIAL LARGE GRID BREAST BIOPSY PLATE

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

K041695

Product Code

LNH

Product Code Name

System, nuclear magnetic resonance imaging

Public Device Record Key

a07be7f7-f16c-48bf-99d5-c4d244b0bf77

Public Version Date

March 11, 2019

Public Version Number

4

DI Record Publish Date

December 01, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-