Catalog Number

71076025

Brand Name

SMART TSF

Version/Model Number

71076025

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K210784

Product Code

JDW

Product Code Name

PIN, FIXATION, THREADED

Public Device Record Key

9714a5a8-2f31-4a54-8bc9-9b3b80fe9c0e

Public Version Date

February 17, 2022

Public Version Number

2

DI Record Publish Date

May 18, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-