Catalog Number

DSL2628

Brand Name

GORE DRYSEAL Sheath

Version/Model Number

DSL2628

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

K121234

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

fcc1cada-461c-42e5-9c20-36ec24a6c8fc

Public Version Date

February 28, 2020

Public Version Number

5

DI Record Publish Date

February 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-