Catalog Number

-

Brand Name

Ti-Cron

Version/Model Number

8886326742-2

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K930591,K930591

Product Code

GAT

Product Code Name

SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Public Device Record Key

5d3bb736-abf5-467a-818d-30c34ef368db

Public Version Date

January 20, 2022

Public Version Number

3

DI Record Publish Date

July 16, 2020

Package DI Number

20884521758756

Quantity per Package

24

Contains DI Package

10884521758759

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE