Catalog Number

-

Brand Name

CorMatrix(R) Cor(TM) PATCH Epicardial Patch, Five Pack, 5cm x 5cm

Version/Model Number

CMCP5P-055

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K181038

Product Code

PSQ

Product Code Name

Intracardiac Patch Or Pledget, Biologically Derived

Public Device Record Key

cf104265-5b16-4770-8d06-c282844be3da

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

December 18, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-