PhotoFix Decellularized Bovine Pericardium PFP1X6

GUDID 00877234000539

Decellularized Bovine Pericardium

Cryolife, Inc.

Cardiovascular patch, animal-derived
Primary Device ID00877234000539
NIH Device Record Keya2a3b29f-7cae-4b1c-ab9c-9b8aea0d59a9
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhotoFix Decellularized Bovine Pericardium
Version Model NumberPFP1X6
Catalog NumberPFP1X6
Company DUNS119253177
Company NameCryolife, Inc.
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-438-8285
Emailxxx@xx.xx
Phone800-438-8285
Emailxxx@xx.xx
Phone800-438-8285
Emailxxx@xx.xx
Phone800-438-8285
Emailxxx@xx.xx
Phone800-438-8285
Emailxxx@xx.xx
Phone800-438-8285
Emailxxx@xx.xx
Phone800-438-8285
Emailxxx@xx.xx
Phone800-438-8285
Emailxxx@xx.xx
Phone800-438-8285
Emailxxx@xx.xx
Phone800-438-8285
Emailxxx@xx.xx
Phone800-438-8285
Emailxxx@xx.xx
Phone800-438-8285
Emailxxx@xx.xx
Phone800-438-8285
Emailxxx@xx.xx

Device Dimensions

Length6 Centimeter
Length6 Centimeter
Width1 Centimeter
Length6 Centimeter
Width1 Centimeter
Length6 Centimeter
Width1 Centimeter
Length6 Centimeter
Width1 Centimeter
Length6 Centimeter
Width1 Centimeter
Length6 Centimeter
Width1 Centimeter
Length6 Centimeter
Width1 Centimeter
Length6 Centimeter
Width1 Centimeter
Length6 Centimeter
Width1 Centimeter
Length6 Centimeter
Width1 Centimeter
Length6 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not place the pericardium in areas where significant temperature fluctuations occur.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not place the pericardium in areas where significant temperature fluctuations occur.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not place the pericardium in areas where significant temperature fluctuations occur.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not place the pericardium in areas where significant temperature fluctuations occur.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not place the pericardium in areas where significant temperature fluctuations occur.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not place the pericardium in areas where significant temperature fluctuations occur.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not place the pericardium in areas where significant temperature fluctuations occur.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not place the pericardium in areas where significant temperature fluctuations occur.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not place the pericardium in areas where significant temperature fluctuations occur.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not place the pericardium in areas where significant temperature fluctuations occur.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100877234000539 [Primary]

FDA Product Code

PSQIntracardiac Patch Or Pledget, Biologically Derived

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2018-01-19

On-Brand Devices [PhotoFix Decellularized Bovine Pericardium]

00877234000652Decellularized Bovine Pericardium
00877234000645Decellularized Bovine Pericardium
00877234000638Decellularized Bovine Pericardium
00877234000522Decellularized Bovine Pericardium
00877234000553Decellularized Bovine Pericardium
00877234000546Decellularized Bovine Pericardium
00877234000539Decellularized Bovine Pericardium
00877234000560Decellularized Bovine Pericardium

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