GORE Hybrid Vascular Graft-CBAS 0650HYB0910A

GUDID H3730650HYB0910A3

HYBRID VG 6-9MM X 10CM US

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 IDH3730650HYB0910A3
NIH Device Record Key00d7052b-a49e-4327-bed7-d126a3dc3f27
Commercial Distribution StatusIn Commercial Distribution
Brand NameGORE Hybrid Vascular Graft-CBAS
Version Model Number0650HYB0910A
Catalog Number0650HYB0910A
Company DUNS967358115
Company NameW. L. Gore & Associates, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
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

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 Diameter9 Millimeter
Length60 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter9 Millimeter
Length60 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter9 Millimeter
Length60 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter9 Millimeter
Length60 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter9 Millimeter
Length60 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter9 Millimeter
Length60 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter9 Millimeter
Length60 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter9 Millimeter
Length60 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter9 Millimeter
Length60 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter9 Millimeter
Length60 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter9 Millimeter
Length60 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter9 Millimeter
Length60 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter9 Millimeter
Length60 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter9 Millimeter
Length60 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter9 Millimeter
Length60 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter9 Millimeter
Length60 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter9 Millimeter
Length60 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter9 Millimeter
Length60 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter9 Millimeter
Length60 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter9 Millimeter
Length60 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter9 Millimeter
Length60 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter9 Millimeter
Length60 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter9 Millimeter
Length60 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter9 Millimeter
Length60 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter9 Millimeter
Length60 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter9 Millimeter
Length60 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter9 Millimeter
Length60 Centimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter9 Millimeter
Length60 Centimeter
Lumen/Inner Diameter6 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100733132618934 [Primary]
HIBCCH3730650HYB0910A3 [Secondary]

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 Date2018-10-29
Device Publish Date2017-02-13

On-Brand Devices [GORE Hybrid Vascular Graft-CBAS]

H3730650HYB0910A3HYBRID VG 6-9MM X 10CM US
H3730650HYB0810A3HYBRID VG 6-8MM X 10CM US
00733132618910HYBRID VG 6-6MM X 10CM US
H3730650HYB0710A3HYBRID VG 6-7MM X 10CM US
H3730650HYB0905A3HYBRID VASCULAR GRAFT 6-9MM US
H3730650HYB0805A3HYBRID VASCULAR GRAFT 6-8MM US
H3730650HYB0705A3HYBRID VASCULAR GRAFT 6-7MM US
H3730650HYB0605A3HYBRID VASCULAR GRAFT 6-6MM US
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