GORE TIPS Set TSET1016

GUDID 00733132657902

GORE TIPS SET 10Fr 3.4mm / 16Ga 1.65mm

W. L. Gore & Associates, Inc.

Vascular catheter introduction set, nonimplantable
Primary Device ID00733132657902
NIH Device Record Key5a74949e-5e13-466e-b641-2a7f221d297a
Commercial Distribution StatusIn Commercial Distribution
Brand NameGORE TIPS Set
Version Model NumberTSET1016
Catalog NumberTSET1016
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 Batchtrue
Serial Numberfalse
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

Phone800-528-8763
Emailmpdcustomercare@wlgore.com
Phone800-528-8763
Emailmpdcustomercare@wlgore.com
Phone800-528-8763
Emailmpdcustomercare@wlgore.com
Phone800-528-8763
Emailmpdcustomercare@wlgore.com
Phone800-528-8763
Emailmpdcustomercare@wlgore.com
Phone800-528-8763
Emailmpdcustomercare@wlgore.com
Phone800-528-8763
Emailmpdcustomercare@wlgore.com
Phone800-528-8763
Emailmpdcustomercare@wlgore.com
Phone800-528-8763
Emailmpdcustomercare@wlgore.com
Phone800-528-8763
Emailmpdcustomercare@wlgore.com
Phone800-528-8763
Emailmpdcustomercare@wlgore.com
Phone800-528-8763
Emailmpdcustomercare@wlgore.com
Phone800-528-8763
Emailmpdcustomercare@wlgore.com
Phone800-528-8763
Emailmpdcustomercare@wlgore.com
Phone800-528-8763
Emailmpdcustomercare@wlgore.com
Phone800-528-8763
Emailmpdcustomercare@wlgore.com
Phone800-528-8763
Emailmpdcustomercare@wlgore.com

Device Dimensions

Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100733132657902 [Primary]

FDA Product Code

DYBIntroducer, Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-23
Device Publish Date2024-07-15

Devices Manufactured by W. L. Gore & Associates, Inc.

00733132658855 - GORE® DrySeal Flex Introducer Sheath2024-12-10 DrySeal Hydro Flex Sheath PI 33cmx10Fr
00733132658862 - GORE® DrySeal Flex Introducer Sheath2024-12-10 DrySeal Hydro Flex Sheath PI 45cmx10Fr
00733132658879 - GORE® DrySeal Flex Introducer Sheath2024-12-10 DrySeal Hydro Flex Sheath PI 65cmx10Fr
00733132658886 - GORE® DrySeal Flex Introducer Sheath2024-12-10 DrySeal Hydro Flex Sheath PI 33cmx11Fr
00733132658893 - GORE® DrySeal Flex Introducer Sheath2024-12-10 DrySeal Hydro Flex Sheath Ao 33cmx12Fr
00733132658909 - GORE® DrySeal Flex Introducer Sheath2024-12-10 DrySeal Hydro Flex Sheath Ao 45cmx12Fr
00733132658916 - GORE® DrySeal Flex Introducer Sheath2024-12-10 DrySeal Hydro Flex Sheath IC 65cmx12Fr
00733132658923 - GORE® DrySeal Flex Introducer Sheath2024-12-10 DrySeal Hydro Flex Sheath Ao 33cmx14Fr

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