Catalog Number

-

Brand Name

ATS SIMULUS®

Version/Model Number

700FC33

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

K052899

Product Code

KRH

Product Code Name

RING, ANNULOPLASTY

Public Device Record Key

fbaf6ee5-206f-4b7d-8c6a-79831bc2f287

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

June 18, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-