Catalog Number

-

Brand Name

Mannequin™ Endoventricular Shaper

Version/Model Number

VRD-0100S

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

K020233

Product Code

DXZ

Product Code Name

Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Public Device Record Key

1eaa4655-9aa2-42c5-bd5b-9bb768b6444d

Public Version Date

May 06, 2020

Public Version Number

5

DI Record Publish Date

May 23, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-