Catalog Number

TARP-27

Brand Name

SJM Tailor™

Version/Model Number

TARP-27

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

K014161

Product Code

KRH

Product Code Name

RING, ANNULOPLASTY

Public Device Record Key

ac4e684b-4f51-484c-96dc-da4944a27503

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

January 07, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-