Catalog Number

-

Brand Name

Ti-Cron

Version/Model Number

XX-2144

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 26, 2020

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

b1dc1d29-36cf-4614-a661-2b4362607fb2

Public Version Date

August 30, 2022

Public Version Number

9

DI Record Publish Date

September 03, 2015

Package DI Number

20884521105307

Quantity per Package

36

Contains DI Package

10884521105300

Package Discontinue Date

August 26, 2020

Package Status

Not in Commercial Distribution

Package Type

CASE