PhotoFix Decellularized Bovine Pericardium PFP1X6

GUDID 00877234000539

Decellularized Bovine Pericardium

Cryolife, Inc.

Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived

• Primary Device ID: 00877234000539
• NIH Device Record Key: a2a3b29f-7cae-4b1c-ab9c-9b8aea0d59a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PhotoFix Decellularized Bovine Pericardium
• Version Model Number: PFP1X6
• Catalog Number: PFP1X6
• Company DUNS: 119253177
• Company Name: Cryolife, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-438-8285
• Email: xxx@xx.xx
• Phone: 800-438-8285
• Email: xxx@xx.xx
• Phone: 800-438-8285
• Email: xxx@xx.xx
• Phone: 800-438-8285
• Email: xxx@xx.xx
• Phone: 800-438-8285
• Email: xxx@xx.xx
• Phone: 800-438-8285
• Email: xxx@xx.xx
• Phone: 800-438-8285
• Email: xxx@xx.xx
• Phone: 800-438-8285
• Email: xxx@xx.xx
• Phone: 800-438-8285
• Email: xxx@xx.xx
• Phone: 800-438-8285
• Email: xxx@xx.xx
• Phone: 800-438-8285
• Email: xxx@xx.xx
• Phone: 800-438-8285
• Email: xxx@xx.xx
• Phone: 800-438-8285
• Email: xxx@xx.xx

Device Dimensions

• Length: 6 Centimeter
• Length: 6 Centimeter
• Width: 1 Centimeter
• Length: 6 Centimeter
• Width: 1 Centimeter
• Length: 6 Centimeter
• Width: 1 Centimeter
• Length: 6 Centimeter
• Width: 1 Centimeter
• Length: 6 Centimeter
• Width: 1 Centimeter
• Length: 6 Centimeter
• Width: 1 Centimeter
• Length: 6 Centimeter
• Width: 1 Centimeter
• Length: 6 Centimeter
• Width: 1 Centimeter
• Length: 6 Centimeter
• Width: 1 Centimeter
• Length: 6 Centimeter
• Width: 1 Centimeter
• Length: 6 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not place the pericardium in areas where significant temperature fluctuations occur.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not place the pericardium in areas where significant temperature fluctuations occur.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not place the pericardium in areas where significant temperature fluctuations occur.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not place the pericardium in areas where significant temperature fluctuations occur.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not place the pericardium in areas where significant temperature fluctuations occur.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not place the pericardium in areas where significant temperature fluctuations occur.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not place the pericardium in areas where significant temperature fluctuations occur.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not place the pericardium in areas where significant temperature fluctuations occur.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not place the pericardium in areas where significant temperature fluctuations occur.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not place the pericardium in areas where significant temperature fluctuations occur.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00877234000539 [Primary]

FDA Product Code

• PSQ: Intracardiac Patch Or Pledget, Biologically Derived

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2018-01-19

On-Brand Devices [PhotoFix Decellularized Bovine Pericardium]

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