GORE-TEX Stretch Vascular Graft-Bifurcated SBT1201D

GUDID 00733132611928

STRETCH BIFUR TW 12-06MM X40CM

W. L. Gore & Associates, Inc.

Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft
Primary Device ID00733132611928
NIH Device Record Key70b9ed3b-13a9-4952-a7f3-5044c6e3ea66
Commercial Distribution StatusIn Commercial Distribution
Brand NameGORE-TEX Stretch Vascular Graft-Bifurcated
Version Model NumberSBT1201D
Catalog NumberSBT1201D
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

Device Dimensions

Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter12 Millimeter
Length40 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter12 Millimeter
Length40 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter12 Millimeter
Length40 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter12 Millimeter
Length40 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter12 Millimeter
Length40 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter12 Millimeter
Length40 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter12 Millimeter
Length40 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter12 Millimeter
Length40 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter12 Millimeter
Length40 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter12 Millimeter
Length40 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter12 Millimeter
Length40 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter12 Millimeter
Length40 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter12 Millimeter
Length40 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter12 Millimeter
Length40 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter12 Millimeter
Length40 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter12 Millimeter
Length40 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter12 Millimeter
Length40 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter12 Millimeter
Length40 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter12 Millimeter
Length40 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter12 Millimeter
Length40 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter12 Millimeter
Length40 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter12 Millimeter
Length40 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter12 Millimeter
Length40 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter12 Millimeter
Length40 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter12 Millimeter
Length40 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter12 Millimeter
Length40 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter12 Millimeter
Length40 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter12 Millimeter
Length40 Centimeter
Lumen/Inner Diameter6 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100733132611928 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSYPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-01-28
Device Publish Date2017-02-13

On-Brand Devices [GORE-TEX Stretch Vascular Graft-Bifurcated]

00733132612109STRETCH BIFUR TW 20-10MM X50CM
00733132612086STRETCH BIFUR TW 20-10MM X40CM
H373SBT1802D3STRETCH BIFUR TW 18-09MM X50CM
H373SBT1801D3STRETCH BIFUR TW 18-09MM X40CM
00733132612024STRETCH BIFUR TW 16-08MM X50CM
00733132612000STRETCH BIFUR TW 16-08MM X40CM
00733132611980STRETCH BIFUR TW 14-07MM X50CM
00733132611966STRETCH BIFUR TW 14-07MM X40CM
00733132611942STRETCH BIFUR TW 12-06MM X50CM
00733132611928STRETCH BIFUR TW 12-06MM X40CM
H373SB2401D34STRETCH BIFUR 24-12MM X 40CM
H373SB2201D32STRETCH BIFUR 22-11MM X 40CM
H373SB2001D30STRETCH BIFUR 20-10MM X 40CM
H373SB1801D37STRETCH BIFUR 18-09MM X 40CM
H373SB1601D35STRETCH BIFUR 16-08MM X 40CM
H373SB1401D33STRETCH BIFUR 14-07MM X 40CM
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.