Catalog Number

022295

Brand Name

LS-5™ ePTFE QUICK LOAD®

Version/Model Number

022295

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K163639,K163639

Product Code

NBY

Product Code Name

SUTURE, SURGICAL, NONABSORBABLE, EXPANDED, POLYTETRAFLOUROETHYLENE

Public Device Record Key

24cbe72d-4b5b-42f9-b0b3-cc41d1e4a470

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

March 13, 2020

Package DI Number

10850200006428

Quantity per Package

12

Contains DI Package

00850200006421

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box