Hemagard Carotid Patch HGKTP08/75CP (1)

GUDID 00384401015185

Hemagard Carotid Patch Knitted Collagen Coated Vascular Patch

INTERVASCULAR SAS

Cardiovascular patch, animal-derived
Primary Device ID00384401015185
NIH Device Record Key50d9a49f-951e-4e8e-9486-9c62baa2ac6a
Commercial Distribution StatusIn Commercial Distribution
Brand NameHemagard Carotid Patch
Version Model NumberHGKTP08/75CP (1)
Catalog NumberHGKTP08/75CP (1)
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

Length75 Millimeter
Length75 Millimeter
Width8 Millimeter
Length75 Millimeter
Width8 Millimeter
Length75 Millimeter
Width8 Millimeter
Length75 Millimeter
Width8 Millimeter
Length75 Millimeter
Width8 Millimeter
Length75 Millimeter
Width8 Millimeter
Length75 Millimeter
Width8 Millimeter
Length75 Millimeter
Width8 Millimeter
Length75 Millimeter
Width8 Millimeter
Length75 Millimeter
Width8 Millimeter
Length75 Millimeter
Width8 Millimeter
Length75 Millimeter
Width8 Millimeter
Length75 Millimeter

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
GS100384401015185 [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 [Hemagard Carotid Patch]

00384401015208Hemagard Carotid Patch Knitted Ultrathin Collagen Coated Vascular Patch
00384401015192Hemagard Carotid Patch Knitted Ultrathin Collagen Coated Vascular Patch
00384401015185Hemagard Carotid Patch Knitted Collagen Coated Vascular Patch
00384401015178Hemagard Carotid Patch Knitted Collagen Coated Vascular Patch
00384401015161Hemagard Carotid Patch Knitted Ultrathin Collagen Coated Vascular Patch
00384401015154Hemagard Carotid Patch Knitted Ultrathin Collagen Coated Vascular Patch
00384401015147Hemagard Carotid Patch Knitted Ultrathin Collagen Coated Vascular Patch
00384401014980Hemagard Carotid Patch Knitted Ultrathin Collagen Coated Vascular Patch
00384401014973Hemagard Carotid Patch Knitted Ultrathin Collagen Coated Vascular Patch
00384401014966Hemagard Carotid Patch Knitted Ultrathin Collagen Coated Vascular Patch
00384401014959Hemagard Carotid Patch Knitted Ultrathin Collagen Coated Vascular Patch
00384401014942Hemagard Carotid Patch Knitted Ultrathin Collagen Coated Vascular Patch
00384401014935Hemagard Carotid Patch Knitted Ultrathin Collagen Coated Vascular Patch
00384401014928Hemagard Carotid Patch Knitted Ultrathin Collagen Coated Vascular Patch
00384401014911Hemagard Carotid Patch Knitted Collagen Coated Vascular Patch
00384401014904Hemagard Carotid Patch Knitted Collagen Coated Vascular Patch
00384401014898Hemagard Carotid Patch Knitted Collagen Coated Vascular Patch

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