Hemacarotid Patch HEK25/100CPUT (1)

GUDID 00384401011248

Hemacarotid Patch Knitted Ultrathin Collagen Coated Vascular Patch

INTERVASCULAR SAS

Cardiovascular patch, animal-derived
Primary Device ID00384401011248
NIH Device Record Key82f38736-a37f-4e96-b334-72e4dfb73e89
Commercial Distribution StatusIn Commercial Distribution
Brand NameHemacarotid Patch
Version Model NumberHEK25/100CPUT (1)
Catalog NumberHEK25/100CPUT (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
Phone+33442084646
Emailcardiovascular.vics@getinge.com

Device Dimensions

Length100 Millimeter
Width25 Millimeter
Length100 Millimeter
Width25 Millimeter
Length100 Millimeter
Width25 Millimeter
Length100 Millimeter
Width25 Millimeter
Length100 Millimeter
Width25 Millimeter
Length100 Millimeter
Width25 Millimeter
Length100 Millimeter
Width25 Millimeter
Length100 Millimeter
Width25 Millimeter
Length100 Millimeter
Width25 Millimeter
Length100 Millimeter
Width25 Millimeter
Length100 Millimeter
Width25 Millimeter
Length100 Millimeter
Width25 Millimeter
Length100 Millimeter
Width25 Millimeter
Length100 Millimeter
Width25 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
Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100384401011248 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-04
Device Publish Date2023-03-27

On-Brand Devices [Hemacarotid Patch]

00384401010715Hemacarotidpatch Knitted Ultrathin Collagen Coated Vascular Patch
00384401010708Hemacarotidpatch Knitted Ultrathin Collagen Coated Vascular Patch
00384401001508Hemacarotidpatch Knitted Ultrathin Collagen Coated Vascular Patch
00384401001492Hemacarotidpatch Knitted Ultrathin Collagen Coated Vascular Patch
00384401001485Hemacarotidpatch Knitted Ultrathin Collagen Coated Vascular Patch
00384401001478Hemacarotidpatch Knitted Ultrathin Collagen Coated Vascular Patch
00384401001461Hemacarotidpatch Knitted Ultrathin Collagen Coated Vascular Patch
00384401001454Hemacarotidpatch Knitted Collagen Coated Vascular Patch
00384401001447Hemacarotidpatch Knitted Collagen Coated Vascular Patch
00384401001430Hemacarotidpatch Knitted Collagen Coated Vascular Patch
00384401001423Hemacarotidpatch Knitted Collagen Coated Vascular Patch
00384401001416Hemacarotidpatch Knitted Collagen Coated Vascular Patch
00384401011248Hemacarotid Patch Knitted Ultrathin Collagen Coated Vascular Patch
00384401011224Hemacarotid Patch Knitted Ultrathin Collagen Coated Vascular Patch

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.