ProxiCor for Pericardial Closure

GUDID 10859389005017

ProxiCor for Pericardial Closure is a decellularized natural scaffold for repairing the pericardium following cardiac surgery.

AZIYO BIOLOGICS, INC.

Cardiovascular patch, animal-derived
Primary Device ID10859389005017
NIH Device Record Keyabd70a9b-3877-4ffe-827b-81eba73791c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameProxiCor for Pericardial Closure
Version Model NumberCMCV-060-402
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

Height15 Centimeter
Height15 Centimeter
Width7 Centimeter
Height15 Centimeter
Width7 Centimeter
Height15 Centimeter
Width7 Centimeter
Height15 Centimeter
Width7 Centimeter
Height15 Centimeter
Width7 Centimeter
Height15 Centimeter
Width7 Centimeter
Height15 Centimeter
Width7 Centimeter
Height15 Centimeter
Width7 Centimeter
Height15 Centimeter
Width7 Centimeter
Height15 Centimeter
Width7 Centimeter
Height15 Centimeter
Width7 Centimeter
Height15 Centimeter
Width7 Centimeter
Height15 Centimeter
Width7 Centimeter
Height15 Centimeter
Width7 Centimeter
Height15 Centimeter
Width7 Centimeter
Height15 Centimeter
Width7 Centimeter
Height15 Centimeter
Width7 Centimeter
Height15 Centimeter
Width7 Centimeter
Height15 Centimeter
Width7 Centimeter
Height15 Centimeter
Width7 Centimeter
Height15 Centimeter
Width7 Centimeter
Height15 Centimeter
Width7 Centimeter
Height15 Centimeter
Width7 Centimeter
Height15 Centimeter
Width7 Centimeter
Height15 Centimeter
Width7 Centimeter
Height15 Centimeter
Width7 Centimeter
Height15 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
GS100859389005010 [Primary]
GS110859389005017 [Package]
Contains: 00859389005010
Package: Carton [5 Units]
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 Number4
Public Version Date2019-03-01
Device Publish Date2015-06-30

On-Brand Devices [ProxiCor for Pericardial Closure]

10859389005017ProxiCor for Pericardial Closure is a decellularized natural scaffold for repairing the pericard
00859389005003ProxiCor for Pericardial Closure is a decellularized natural scaffold for repairing the pericard

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