Catalog Number

CMUS-10NS-1015

Brand Name

CardiaMend

Version/Model Number

CMUS-10NS-1015

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

K210331

Product Code

PSQ

Product Code Name

Intracardiac Patch Or Pledget, Biologically Derived

Public Device Record Key

66b2085b-3576-4274-aad4-74a5df14af2d

Public Version Date

February 09, 2022

Public Version Number

1

DI Record Publish Date

February 01, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-