Catalog Number

-

Brand Name

KLOSURE

Version/Model Number

9604016001

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

-

Product Code

NBY

Product Code Name

Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

Public Device Record Key

3fa37a94-b45a-4615-beae-a273d410fdae

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 09, 2017

Package DI Number

10812444026631

Quantity per Package

12

Contains DI Package

00812444026634

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-