Catalog Number

C0406A

Brand Name

CardioCel 3D

Version/Model Number

UC0406A

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

K170951

Product Code

PSQ

Product Code Name

Intracardiac Patch Or Pledget, Biologically Derived

Public Device Record Key

17deae43-aca4-4d89-80cd-70f5a06b140e

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

May 09, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-