GORE DrySeal Sheath SDV2628

GUDID 00733132612185

SDV INTRODUCER SHEATH 26F

W. L. Gore & Associates, Inc.

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Primary Device ID00733132612185
NIH Device Record Keyd9a19e08-675c-4389-aebf-5b55e75e995e
Commercial Distribution StatusIn Commercial Distribution
Brand NameGORE DrySeal Sheath
Version Model NumberSDV2628
Catalog NumberSDV2628
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 Datefalse
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

Device Dimensions

Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Length28 Centimeter
Outer Diameter10 Millimeter
Length28 Centimeter
Outer Diameter10 Millimeter
Length28 Centimeter
Outer Diameter10 Millimeter
Length28 Centimeter
Outer Diameter10 Millimeter
Length28 Centimeter
Outer Diameter10 Millimeter
Length28 Centimeter
Outer Diameter10 Millimeter
Length28 Centimeter
Outer Diameter10 Millimeter
Length28 Centimeter
Outer Diameter10 Millimeter
Length28 Centimeter
Outer Diameter10 Millimeter
Length28 Centimeter
Outer Diameter10 Millimeter
Length28 Centimeter
Outer Diameter10 Millimeter
Length28 Centimeter
Outer Diameter10 Millimeter
Length28 Centimeter
Outer Diameter10 Millimeter
Length28 Centimeter
Outer Diameter10 Millimeter
Length28 Centimeter
Outer Diameter10 Millimeter
Length28 Centimeter
Outer Diameter10 Millimeter
Length28 Centimeter
Outer Diameter10 Millimeter
Length28 Centimeter
Outer Diameter10 Millimeter
Length28 Centimeter
Outer Diameter10 Millimeter
Length28 Centimeter
Outer Diameter10 Millimeter
Length28 Centimeter
Outer Diameter10 Millimeter
Length28 Centimeter
Outer Diameter10 Millimeter
Length28 Centimeter
Outer Diameter10 Millimeter
Length28 Centimeter
Outer Diameter10 Millimeter
Length28 Centimeter
Outer Diameter10 Millimeter
Length28 Centimeter
Outer Diameter10 Millimeter
Length28 Centimeter
Outer Diameter10 Millimeter
Length28 Centimeter
Outer Diameter10 Millimeter
Length28 Centimeter
Outer Diameter10 Millimeter
Length28 Centimeter
Outer Diameter10 Millimeter
Length28 Centimeter
Outer Diameter10 Millimeter
Length28 Centimeter
Outer Diameter10 Millimeter
Length28 Centimeter
Outer Diameter10 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100733132612185 [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 Date2017-02-13

On-Brand Devices [GORE DrySeal Sheath]

00733132620005DRYSEAL LUBRICIOUS 26F Hydrophilic Coating
00733132619993DRYSEAL LUBRICIOUS 24F Hydrophilic Coating
00733132619986DRYSEAL LUBRICIOUS 22F Hydrophilic Coating
00733132619979DRYSEAL LUBRICIOUS 20F Hydrophilic Coating
00733132619962DRYSEAL LUBRICIOUS 18F Hydrophilic Coating
00733132619955DRYSEAL LUBRICIOUS 16F Hydrophilic Coating
00733132619948DRYSEAL LUBRICIOUS 14F Hydrophilic Coating
00733132619931DRYSEAL LUBRICIOUS 12F
00733132612185SDV INTRODUCER SHEATH 26F
00733132612178SDV INTRODUCER SHEATH 24F
00733132612161SDV INTRODUCER SHEATH 22F
00733132612154SDV INTRODUCER SHEATH 20F
H373SDV18283SDV INTRODUCER SHEATH 18F
00733132612123SDV INTRODUCER SHEATH 14F
00733132612116SDV INTRODUCER SHEATH 12F

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