Hemagard HGKUT0008-40

GUDID 00384401014768

Hemagard Knitted Ultrathin Straight Collagen Coated Vascular Graft

INTERVASCULAR SAS

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 ID00384401014768
NIH Device Record Keye024f7dd-29d7-4b84-a07d-95ff956dfaf2
Commercial Distribution StatusIn Commercial Distribution
Brand NameHemagard
Version Model NumberHGKUT0008-40
Catalog NumberHGKUT0008-40
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

Length40 Centimeter
Length40 Centimeter
Lumen/Inner Diameter8 Millimeter
Length40 Centimeter
Lumen/Inner Diameter8 Millimeter
Length40 Centimeter
Lumen/Inner Diameter8 Millimeter
Length40 Centimeter
Lumen/Inner Diameter8 Millimeter
Length40 Centimeter
Lumen/Inner Diameter8 Millimeter
Length40 Centimeter
Lumen/Inner Diameter8 Millimeter
Length40 Centimeter
Lumen/Inner Diameter8 Millimeter
Length40 Centimeter
Lumen/Inner Diameter8 Millimeter
Length40 Centimeter
Lumen/Inner Diameter8 Millimeter
Length40 Centimeter
Lumen/Inner Diameter8 Millimeter
Length40 Centimeter
Lumen/Inner Diameter8 Millimeter
Length40 Centimeter
Lumen/Inner Diameter8 Millimeter
Length40 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
GS100384401014768 [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 Date2015-09-25

On-Brand Devices [Hemagard]

00384401015314Hemagard Knitted Straight Collagen Coated Vascular Graft
00384401015109Hemagard Knitted Axillo-bifemoral Collagen Coated Vascular Graft
00384401015093Hemagard Knitted Straight Collagen Coated Vascular Graft
00384401015086Hemagard Knitted Straight Collagen Coated Vascular Graft
00384401015079Hemagard Knitted Straight Collagen Coated Vascular Graft
00384401015062Hemagard Knitted Bifurcated Collagen Coated Vascular Graft
00384401015055Hemagard Knitted Bifurcated Collagen Coated Vascular Graft
00384401015048Hemagard Knitted Bifurcated Collagen Coated Vascular Graft
00384401015031Hemagard Knitted Bifurcated Collagen Coated Vascular Graft
00384401015017Hemagard Knitted Bifurcated Collagen Coated Vascular Graft
00384401014812Hemagard Knitted Axillo-bifemoral Radially Supported Collagen Coated Vascular Graft
00384401014805Hemagard Knitted Ultrathin Straight Radially Supported Collagen Coated Vascular Graft
00384401014799Hemagard Knitted Ultrathin Straight Radially Supported Collagen Coated Vascular Graft
00384401014782Hemagard Knitted Ultrathin Straight Radially Supported Collagen Coated Vascular Graft
00384401014775Hemagard Knitted Ultrathin Straight Collagen Coated Vascular Graft
00384401014768Hemagard Knitted Ultrathin Straight Collagen Coated Vascular Graft
00384401014751Hemagard Knitted Ultrathin Straight Collagen Coated Vascular Graft
00384401014744Hemagard Knitted Ultrathin Straight Radially Supported Collagen Coated Vascular Graft
00384401014737Hemagard Knitted Ultrathin Straight Radially Supported Collagen Coated Vascular Graft
00384401014720Hemagard Knitted Ultrathin Straight Collagen Coated Vascular Graft
00384401014713Hemagard Knitted Ultrathin Straight Collagen Coated Vascular Graft
00384401014706Hemagard Knitted Ultrathin Straight Collagen Coated Vascular Graft
00384401014690Hemagard Knitted Ultrathin Straight Radially Supported Collagen Coated Vascular Graft
00384401014683Hemagard Knitted Ultrathin Straight Collagen Coated Vascular Graft
00384401014676Hemagard Knitted Ultrathin Straight Collagen Coated Vascular Graft
00384401014669Hemagard Knitted Ultrathin Straight Collagen Coated Vascular Graft
00384401014478Hemagard Knitted Axillo-bifemoral Collagen Coated Vascular Graft
00384401014461Hemagard Knitted Axillo-bifemoral Radially Supported Collagen Coated Vascular Graft
00384401014454Hemagard Knitted Axillo-bifemoral Radially Supported Collagen Coated Vascular Graft
00384401014447Hemagard Knitted Axillo-bifemoral Radially Supported Collagen Coated Vascular Graft
00384401014430Hemagard Knitted Axillo-bifemoral Radially Supported Collagen Coated Vascular Graft
00384401014423Hemagard Knitted Bifurcated Collagen Coated Vascular Graft
00384401014416Hemagard Knitted Bifurcated Collagen Coated Vascular Graft
00384401014409Hemagard Knitted Bifurcated Collagen Coated Vascular Graft
00384401014393Hemagard Knitted Bifurcated Collagen Coated Vascular Graft
00384401014386Hemagard Knitted Bifurcated Collagen Coated Vascular Graft
00384401014379Hemagard Knitted Bifurcated Collagen Coated Vascular Graft
00384401014362Hemagard Knitted Straight Collagen Coated Vascular Graft
00384401014355Hemagard Knitted Straight Collagen Coated Vascular Graft
00384401014348Hemagard Knitted Straight Collagen Coated Vascular Graft
00384401014331Hemagard Knitted Straight Collagen Coated Vascular Graft
00384401014324Hemagard Knitted Straight Collagen Coated Vascular Graft
00384401014317Hemagard Knitted Straight Collagen Coated Vascular Graft
00384401014300Hemagard Knitted Straight Collagen Coated Vascular Graft
00384401014294Hemagard Knitted Straight Collagen Coated Vascular Graft
00384401014287Hemagard Knitted Straight Collagen Coated Vascular Graft
00384401014270Hemagard Knitted Straight Collagen Coated Vascular Graft
00384401014263Hemagard Knitted Straight Collagen Coated Vascular Graft
00384401014256Hemagard Knitted Straight Collagen Coated Vascular Graft
00384401014249Hemagard Knitted Straight Collagen Coated Vascular Graft

Trademark Results [Hemagard]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HEMAGARD
HEMAGARD
85288714 4254635 Live/Registered
Maquet Cardiovascular LLC
2011-04-07
HEMAGARD
HEMAGARD
73825384 not registered Dead/Abandoned
HEMACARE CORPORATION
1989-09-14
HEMAGARD
HEMAGARD
72436945 0992604 Dead/Expired
CLIPP, WENDELL V.
1972-09-28
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.