Intergard IGK0006RS20

GUDID 00384401000716

Intergard Knitted Straight Radially Supported Collagen Coated Vascular Graft

INTERVASCULAR SAS

Synthetic vascular graft
Primary Device ID00384401000716
NIH Device Record Key4d6d42be-8f73-4eb8-81bd-f1dbae78efd7
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntergard
Version Model NumberIGK0006RS20
Catalog NumberIGK0006RS20
Company DUNS382174019
Company NameINTERVASCULAR SAS
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 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+33442084646
Emailcardiovascular.vics@getinge.com
Phone+33442084646
Emailcardiovascular.vics@getinge.com
Phone+33442084646
Emailcardiovascular.vics@getinge.com
Phone+33442084646
Emailcardiovascular.vics@getinge.com
Phone+33442084646
Emailcardiovascular.vics@getinge.com
Phone+33442084646
Emailcardiovascular.vics@getinge.com
Phone+33442084646
Emailcardiovascular.vics@getinge.com
Phone+33442084646
Emailcardiovascular.vics@getinge.com
Phone+33442084646
Emailcardiovascular.vics@getinge.com
Phone+33442084646
Emailcardiovascular.vics@getinge.com
Phone+33442084646
Emailcardiovascular.vics@getinge.com
Phone+33442084646
Emailcardiovascular.vics@getinge.com
Phone+33442084646
Emailcardiovascular.vics@getinge.com

Device Dimensions

Length70 Centimeter
Length70 Centimeter
Lumen/Inner Diameter6 Millimeter
Length70 Centimeter
Lumen/Inner Diameter6 Millimeter
Length70 Centimeter
Lumen/Inner Diameter6 Millimeter
Length70 Centimeter
Lumen/Inner Diameter6 Millimeter
Length70 Centimeter
Lumen/Inner Diameter6 Millimeter
Length70 Centimeter
Lumen/Inner Diameter6 Millimeter
Length70 Centimeter
Lumen/Inner Diameter6 Millimeter
Length70 Centimeter
Lumen/Inner Diameter6 Millimeter
Length70 Centimeter
Lumen/Inner Diameter6 Millimeter
Length70 Centimeter
Lumen/Inner Diameter6 Millimeter
Length70 Centimeter
Lumen/Inner Diameter6 Millimeter
Length70 Centimeter
Lumen/Inner Diameter6 Millimeter
Length70 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100384401000716 [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 Number3
Public Version Date2018-07-06
Device Publish Date2015-09-24

On-Brand Devices [Intergard]

00384401103868Intergard Woven Aortic Arch Collagen Coated Vascular Graft
00384401103851Intergard Woven Aortic Arch Collagen Coated Vascular Graft
00384401103844Intergard Woven Aortic Arch Collagen Coated Vascular Graft
00384401010760Intergard Woven Aortic Arch Collagen Coated Vascular Graft
00384401010753Intergard Woven Aortic Arch Collagen Coated Vascular Graft
00384401010746Intergard Woven Aortic Arch Collagen Coated Vascular Graft
00384401010739Intergard Woven Aortic Arch Collagen Coated Vascular Graft
00384401010722Intergard Woven Aortic Arch Collagen Coated Vascular Graft
00384401007593Intergard Knitted Straight Collagen Coated Vascular Graft
00384401007586Intergard Knitted Straight Collagen Coated Vascular Graft
00384401007562Intergard Knitted Straight Collagen Coated Vascular Graft
00384401007555Intergard Knitted Straight Collagen Coated Vascular Graft
00384401007340Intergard Woven Straight Collagen Coated Vascular Graft
00384401007265Intergard Woven Hemabridge Collagen Coated Vascular Graft
00384401006930Intergard Woven Hemabridge Collagen Coated Vascular Graft
00384401006459Intergard Woven Straight Collagen Coated Vascular Graft
00384401006190Intergard Woven Hemabridge Collagen Coated Vascular Graft
00384401006039Intergard Knitted Axillo-bifemoral Radially Supported Collagen Coated Vascular Graft
00384401005902Intergard Woven Straight Collagen Coated Vascular Graft
00384401005896Intergard Woven Straight Collagen Coated Vascular Graft
00384401005889Intergard Woven Straight Collagen Coated Vascular Graft
00384401005872Intergard Woven Straight Collagen Coated Vascular Graft
00384401004028Intergard Knitted Straight Radially Supported Collagen Coated Vascular Graft
00384401001614Intergard Knitted Axillo-bifemoral Radially Supported Collagen Coated Vascular Graft
00384401001607Intergard Knitted Straight Collagen Coated Vascular Graft
00384401001409Intergard Knitted Straight Collagen Coated Vascular Graft
00384401001393Intergard Knitted Straight Collagen Coated Vascular Graft
00384401001386Intergard Woven Hemabridge Collagen Coated Vascular Graft
00384401001379Intergard Knitted Ultrathin Straight Radially Supported Collagen Coated Vascular Graft
00384401001362Intergard Knitted Ultrathin Straight Radially Supported Collagen Coated Vascular Graft
00384401001355Intergard Knitted Straight Collagen Coated Vascular Graft
00384401001294Intergard Knitted Ultrathin Straight Radially Supported Collagen Coated Vascular Graft
00384401001270Intergard Knitted Ultrathin Straight Collagen Coated Vascular Graft
00384401001263Intergard Knitted Ultrathin Straight Collagen Coated Vascular Graft
00384401001249Intergard Woven Hemabridge Collagen Coated Vascular Graft
00384401001232Intergard Woven Hemabridge Collagen Coated Vascular Graft
00384401001225Intergard Knitted Ultrathin Straight Collagen Coated Vascular Graft
00384401001218Intergard Knitted Ultrathin Straight Radially Supported Collagen Coated Vascular Graft
00384401001201Intergard Knitted Ultrathin Straight Radially Supported Collagen Coated Vascular Graft
00384401001195Intergard Knitted Ultrathin Straight Radially Supported Collagen Coated Vascular Graft
00384401001171Intergard Knitted Ultrathin Straight Collagen Coated Vascular Graft
00384401001164Intergard Knitted Ultrathin Straight Collagen Coated Vascular Graft
00384401001157Intergard Knitted Ultrathin Straight Collagen Coated Vascular Graft
00384401001102Intergard Knitted Axillo-bifemoral Collagen Coated Vascular Graft
00384401001034Intergard Woven Hemabridge Collagen Coated Vascular Graft
00384401001027Intergard Woven Hemabridge Collagen Coated Vascular Graft
00384401001010Intergard Woven Hemabridge Collagen Coated Vascular Graft
00384401000990Intergard Knitted Straight Collagen Coated Vascular Graft
00384401000983Intergard Knitted Straight Collagen Coated Vascular Graft
00384401000976Intergard Knitted Straight Collagen Coated Vascular Graft

Trademark Results [Intergard]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INTERGARD
INTERGARD
77645078 3654477 Live/Registered
INTERGARD DO BRASIL INDUSTRIA E COMERCIO DE ELETRONICOS E MECANICOS LTDA
2009-01-07
INTERGARD
INTERGARD
74488462 2173217 Live/Registered
DATASCOPE CORP.
1994-02-09
INTERGARD
INTERGARD
74462938 not registered Dead/Abandoned
Ciba-Geigy Corporation
1993-11-24
INTERGARD
INTERGARD
73650558 1463258 Dead/Cancelled
CIBA-GEIGY CORPORATION
1987-03-20
INTERGARD
INTERGARD
73394847 1289651 Live/Registered
International Paint Company, Inc.
1982-09-30
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.