GORE DRYSEAL FLEX Introducer Sheath DSF1533

GUDID 00733132630011

W. L. Gore & Associates, Inc.

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Primary Device ID00733132630011
NIH Device Record Keyd8a1ad7a-7e81-4799-8195-bb0063b5f326
Commercial Distribution StatusIn Commercial Distribution
Brand NameGORE DRYSEAL FLEX Introducer Sheath
Version Model NumberDSF1533
Catalog NumberDSF1533
Company DUNS967358115
Company NameW. L. Gore & Associates, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com
Phone+1(800)528-8763
Emailmpdcustomercare@wlgore.com

Device Dimensions

Catheter Gauge15 French
Catheter Gauge15 French
Catheter Gauge15 French
Catheter Gauge15 French
Length33 Centimeter
Catheter Gauge15 French
Length33 Centimeter
Catheter Gauge15 French
Length33 Centimeter
Catheter Gauge15 French
Length33 Centimeter
Catheter Gauge15 French
Length33 Centimeter
Catheter Gauge15 French
Length33 Centimeter
Catheter Gauge15 French
Length33 Centimeter
Catheter Gauge15 French
Length33 Centimeter
Catheter Gauge15 French
Length33 Centimeter
Catheter Gauge15 French
Length33 Centimeter
Catheter Gauge15 French
Length33 Centimeter
Catheter Gauge15 French
Length33 Centimeter
Catheter Gauge15 French
Length33 Centimeter
Catheter Gauge15 French
Length33 Centimeter
Catheter Gauge15 French
Length33 Centimeter
Catheter Gauge15 French
Length33 Centimeter
Catheter Gauge15 French
Length33 Centimeter
Catheter Gauge15 French
Length33 Centimeter
Catheter Gauge15 French
Length33 Centimeter
Catheter Gauge15 French
Length33 Centimeter
Catheter Gauge15 French
Length33 Centimeter
Catheter Gauge15 French
Length33 Centimeter
Catheter Gauge15 French
Length33 Centimeter
Catheter Gauge15 French
Length33 Centimeter
Catheter Gauge15 French
Length33 Centimeter
Catheter Gauge15 French
Length33 Centimeter
Catheter Gauge15 French
Length33 Centimeter
Catheter Gauge15 French
Length33 Centimeter
Catheter Gauge15 French
Length33 Centimeter
Catheter Gauge15 French
Length33 Centimeter
Catheter Gauge15 French
Length33 Centimeter
Catheter Gauge15 French
Length33 Centimeter
Catheter Gauge15 French
Length33 Centimeter
Catheter Gauge15 French
Length33 Centimeter
Catheter Gauge15 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100733132630011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYBINTRODUCER, CATHETER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-28
Device Publish Date2016-07-22

On-Brand Devices [GORE DRYSEAL FLEX Introducer Sheath]

00733132630950DSF2433
00733132630103DSF2633
00733132630073DSF2233
00733132630066DSF2033
00733132630042DSF1833
00733132630028DSF1633
00733132630011DSF1533
00733132630004DSF1433
00733132629961DSF1233
00733132628421DSF2665
00733132628407DSF2465
00733132628384DSF2265
00733132628360DSF2065
00733132628117DSF1245
00733132629978DSF1033
00733132628261DSF1065
00733132628094DSF1045
00733132628346DSF1865
00733132628322DSF1665
00733132628308DSF1465
00733132628285DSF1265
00733132629985GORE DRYSEAL FLEX Introducer Sheath 33cm 11Fr Hydrophilic Coating

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