CorMatrix(R) Cor(TM) PATCH Epicardial Patch, Five Pack, 5cm x 5cm

GUDID 00850003965000

CorMatrix Cor PATCH is intended for epicardial tissue support and repair.

CORMATRIX CARDIOVASCULAR, INC.

Cardiovascular patch, animal-derived
Primary Device ID00850003965000
NIH Device Record Keycf104265-5b16-4770-8d06-c282844be3da
Commercial Distribution StatusIn Commercial Distribution
Brand NameCorMatrix(R) Cor(TM) PATCH Epicardial Patch, Five Pack, 5cm x 5cm
Version Model NumberCMCP5P-055
Company DUNS601217164
Company NameCORMATRIX CARDIOVASCULAR, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length5 Centimeter
Length5 Centimeter
Length5 Centimeter
Length5 Centimeter
Length5 Centimeter
Length5 Centimeter
Length5 Centimeter
Length5 Centimeter
Length5 Centimeter
Length5 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850003965000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PSQIntracardiac Patch Or Pledget, Biologically Derived

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-01-18
Device Publish Date2018-12-18

Devices Manufactured by CORMATRIX CARDIOVASCULAR, INC.

00850003965000 - CorMatrix(R) Cor(TM) PATCH Epicardial Patch, Five Pack, 5cm x 5cm2019-01-18CorMatrix Cor PATCH is intended for epicardial tissue support and repair.
00850003965000 - CorMatrix(R) Cor(TM) PATCH Epicardial Patch, Five Pack, 5cm x 5cm2019-01-18 CorMatrix Cor PATCH is intended for epicardial tissue support and repair.
00850003965017 - CorMatrix(R) Cor(TM) PATCH Epicardial Patch, Five Pack, 7cm x 10cm2019-01-18 CorMatrix Cor PATCH is intended for epicardial tissue support and repair.

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