VascuCel V2080

GUDID 09348992000532

VascuCel is prepared from bovine pericardium using the ADAPT® Tissue Processing Technology. The pericardium is procured from cattle originating in Au

ADMEDUS REGEN PTY LTD

Cardiovascular patch, animal-derived
Primary Device ID09348992000532
NIH Device Record Keyc881f824-d415-4a4c-9c9f-2daa0a922ff8
Commercial Distribution StatusIn Commercial Distribution
Brand NameVascuCel
Version Model NumberUV2080
Catalog NumberV2080
Company DUNS741172167
Company NameADMEDUS REGEN PTY LTD
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 Numberfalse
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+61892660100
Emailinfo@admedus.com
Phone+61892660100
Emailinfo@admedus.com
Phone+61892660100
Emailinfo@admedus.com
Phone+61892660100
Emailinfo@admedus.com
Phone+61892660100
Emailinfo@admedus.com
Phone+61892660100
Emailinfo@admedus.com
Phone+61892660100
Emailinfo@admedus.com
Phone+61892660100
Emailinfo@admedus.com
Phone+61892660100
Emailinfo@admedus.com
Phone+61892660100
Emailinfo@admedus.com

Device Dimensions

Length2 Centimeter
Width8 Centimeter
Length2 Centimeter
Width8 Centimeter
Length2 Centimeter
Width8 Centimeter
Length2 Centimeter
Width8 Centimeter
Length2 Centimeter
Width8 Centimeter
Length2 Centimeter
Width8 Centimeter
Length2 Centimeter
Width8 Centimeter
Length2 Centimeter
Width8 Centimeter
Length2 Centimeter
Width8 Centimeter
Length2 Centimeter
Width8 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS109348992000532 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-29
Device Publish Date2019-03-21

On-Brand Devices [VascuCel]

09348992000563VascuCel is prepared from bovine pericardium using the ADAPT® Tissue Processing Technology. Th
09348992000532VascuCel is prepared from bovine pericardium using the ADAPT® Tissue Processing Technology. Th
09348992000525VascuCel is prepared from bovine pericardium using the ADAPT® Tissue Processing Technology. Th
09348992000303UV1014
09348992000273The VascuCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pe
09348992000266The VascuCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pe

Trademark Results [VascuCel]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VASCUCEL
VASCUCEL
86770130 5080486 Live/Registered
LEMAITRE VASCULAR, INC.
2015-09-28

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