Catalog Number

-

Brand Name

TSI

Version/Model Number

TK-0400S

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GDG

Product Code Name

Hook, Surgical, General & Plastic Surgery

Public Device Record Key

09f02a2a-2223-4f70-a2bf-c0643439b524

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 10, 2017

Package DI Number

10843059116332

Quantity per Package

5

Contains DI Package

00843059116335

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack