Catalog Number

-

Brand Name

M-Core

Version/Model Number

MC1825

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

5355aa8f-d0e4-411a-bea6-3de4d9689042

Public Version Date

July 12, 2019

Public Version Number

2

DI Record Publish Date

February 08, 2019

Package DI Number

B567MC18251

Quantity per Package

10

Contains DI Package

B567MC18250

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box