Ti-Cron - Coated Braided Polyester - Covidien LP

Duns Number:058614483

Device Description: Coated Braided Polyester

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More Product Details

Catalog Number

-

Brand Name

Ti-Cron

Version/Model Number

88863134-61

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 05, 2016

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

GAT

Product Code Name

SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Device Record Status

Public Device Record Key

633bc189-195e-4085-a54d-6513a94e4935

Public Version Date

August 26, 2022

Public Version Number

7

DI Record Publish Date

August 31, 2015

Additional Identifiers

Package DI Number

20884521163857

Quantity per Package

36

Contains DI Package

10884521163850

Package Discontinue Date

April 05, 2016

Package Status

Not in Commercial Distribution

Package Type

CASE

"COVIDIEN LP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 132
2 A medical device with a moderate to high risk that requires special controls. 8540
3 A medical device with high risk that requires premarket approval 202
U Unclassified 40