Catalog Number

-

Brand Name

Simulus™

Version/Model Number

850

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DTI

Product Code Name

SIZER, HEART-VALVE, PROSTHESIS

Public Device Record Key

d0e536aa-d92e-4e72-834b-ccf0a0a76992

Public Version Date

June 14, 2021

Public Version Number

1

DI Record Publish Date

June 06, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-