ProxiCor for Cardiac Tissue Repair

GUDID 10859389005055

ProxiCor for Cardiac Tissue Repair is indicated for use as an intracardiac patch or pledget for tissue repair and suture-line buttressing.

AZIYO BIOLOGICS, INC.

Cardiovascular patch, animal-derived
Primary Device ID10859389005055
NIH Device Record Key95e52f4c-7ea0-49cf-997f-b94271e5ff79
Commercial Distribution StatusIn Commercial Distribution
Brand NameProxiCor for Cardiac Tissue Repair
Version Model NumberCMCV-067-404
Company DUNS080251450
Company NameAZIYO BIOLOGICS, 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

Customer Support Contacts

Phone470-514-4080
Emailxxx@xx.xx
Phone470-514-4080
Emailxxx@xx.xx
Phone470-514-4080
Emailxxx@xx.xx
Phone470-514-4080
Emailxxx@xx.xx
Phone470-514-4080
Emailxxx@xx.xx
Phone470-514-4080
Emailxxx@xx.xx
Phone470-514-4080
Emailxxx@xx.xx
Phone470-514-4080
Emailxxx@xx.xx
Phone470-514-4080
Emailxxx@xx.xx
Phone470-514-4080
Emailxxx@xx.xx
Phone470-514-4080
Emailxxx@xx.xx
Phone470-514-4080
Emailxxx@xx.xx
Phone470-514-4080
Emailxxx@xx.xx
Phone470-514-4080
Emailxxx@xx.xx
Phone470-514-4080
Emailxxx@xx.xx
Phone470-514-4080
Emailxxx@xx.xx
Phone470-514-4080
Emailxxx@xx.xx
Phone470-514-4080
Emailxxx@xx.xx
Phone470-514-4080
Emailxxx@xx.xx
Phone470-514-4080
Emailxxx@xx.xx
Phone470-514-4080
Emailxxx@xx.xx
Phone470-514-4080
Emailxxx@xx.xx
Phone470-514-4080
Emailxxx@xx.xx
Phone470-514-4080
Emailxxx@xx.xx
Phone470-514-4080
Emailxxx@xx.xx
Phone470-514-4080
Emailxxx@xx.xx
Phone470-514-4080
Emailxxx@xx.xx
Phone470-514-4080
Emailxxx@xx.xx
Phone470-514-4080
Emailxxx@xx.xx

Device Dimensions

Height4 Centimeter
Height4 Centimeter
Width7 Centimeter
Height4 Centimeter
Width7 Centimeter
Height4 Centimeter
Width7 Centimeter
Height4 Centimeter
Width7 Centimeter
Height4 Centimeter
Width7 Centimeter
Height4 Centimeter
Width7 Centimeter
Height4 Centimeter
Width7 Centimeter
Height4 Centimeter
Width7 Centimeter
Height4 Centimeter
Width7 Centimeter
Height4 Centimeter
Width7 Centimeter
Height4 Centimeter
Width7 Centimeter
Height4 Centimeter
Width7 Centimeter
Height4 Centimeter
Width7 Centimeter
Height4 Centimeter
Width7 Centimeter
Height4 Centimeter
Width7 Centimeter
Height4 Centimeter
Width7 Centimeter
Height4 Centimeter
Width7 Centimeter
Height4 Centimeter
Width7 Centimeter
Height4 Centimeter
Width7 Centimeter
Height4 Centimeter
Width7 Centimeter
Height4 Centimeter
Width7 Centimeter
Height4 Centimeter
Width7 Centimeter
Height4 Centimeter
Width7 Centimeter
Height4 Centimeter
Width7 Centimeter
Height4 Centimeter
Width7 Centimeter
Height4 Centimeter
Width7 Centimeter
Height4 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100859389005058 [Primary]
GS110859389005055 [Package]
Contains: 00859389005058
Package: Box [5 Units]
Discontinued: 2018-12-31
Not in Commercial Distribution

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 StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-03-01
Device Publish Date2015-07-01

On-Brand Devices [ProxiCor for Cardiac Tissue Repair]

10859389005055ProxiCor for Cardiac Tissue Repair is indicated for use as an intracardiac patch or pledget for
10859389005048ProxiCor for Cardiac Tissue Repair is indicated for use as an intracardiac patch or pledget for

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