GORE DRYSEAL FLEX Introducer Sheath - W. L. Gore & Associates, Inc.

Duns Number:967358115

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More Product Details

Catalog Number

DSF1633

Brand Name

GORE DRYSEAL FLEX Introducer Sheath

Version/Model Number

DSF1633

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K160254

Product Code Details

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Device Record Status

Public Device Record Key

0956ddd3-8d9d-4d8b-b34a-aa86d92698d3

Public Version Date

February 28, 2020

Public Version Number

4

DI Record Publish Date

July 22, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"W. L. GORE & ASSOCIATES, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 561
3 A medical device with high risk that requires premarket approval 623