Catalog Number

-

Brand Name

Ti-Cron

Version/Model Number

X1384

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 12, 2021

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

a763df06-5cd5-4d5d-884f-6e23d1aead84

Public Version Date

January 20, 2022

Public Version Number

7

DI Record Publish Date

October 11, 2017

Package DI Number

20884521726663

Quantity per Package

6

Contains DI Package

10884521726666

Package Discontinue Date

February 12, 2021

Package Status

Not in Commercial Distribution

Package Type

PACK_OR_INNER_PACK