Catalog Number

DSF1533

Brand Name

GORE DRYSEAL FLEX Introducer Sheath

Version/Model Number

DSF1533

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

K160254

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

d8a1ad7a-7e81-4799-8195-bb0063b5f326

Public Version Date

February 28, 2020

Public Version Number

4

DI Record Publish Date

July 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-