Catalog Number

-

Brand Name

Ti-Cron

Version/Model Number

88863131-56

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 22, 2022

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

97a7cea9-d9d3-48c5-bd3e-406d753142ef

Public Version Date

April 26, 2022

Public Version Number

7

DI Record Publish Date

August 31, 2015

Package DI Number

20884521163826

Quantity per Package

6

Contains DI Package

10884521163829

Package Discontinue Date

April 22, 2022

Package Status

Not in Commercial Distribution

Package Type

CASE