Cryolife, Inc.

Address:1655 Roberts Blvd NW,Kennesaw,GA,30144,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Intracardiac Patch Or Pledget, Biologically Derived (PSQ) (8) Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (DXZ) (2)

Premarket Exempt

Clear

CryoPatch® SG Pulmonary Human Cardiac Trunk Patch - 00877234000478 Catalog Number : SGP010

Device Description : CryoPatch SG Pulmonary TrunkThe CryoPatch SG Pulmonary Human Cardiac Patch is a CryoPatch SG Pulmonary TrunkThe CryoPatch SG Pulmonary Human Cardiac Patch is a human heart valve aseptically recovered from donated human tissue.

Device Class : 2

Duns Number: 119253177

Premarket Exempt : No

Product Code : DXZ

Prescription Use : Yes

Device Count : 1

CryoPatch® SG Pulmonary Human Cardiac Branch Patch - 00877234000485 Catalog Number : SGP020

Device Description : CryoPatch SG Pulmonary BranchThe CryoPatch SG Pulmonary Human Cardiac Patch is a CryoPatch SG Pulmonary BranchThe CryoPatch SG Pulmonary Human Cardiac Patch is a human heart valve aseptically recovered from donated human tissue.

Device Class : 2

Duns Number: 119253177

Premarket Exempt : No

Product Code : DXZ

Prescription Use : Yes

Device Count : 1

PhotoFix Decellularized Bovine Pericardium - 00877234000522 Catalog Number : PFP 6x8

Device Description : Decellularized Bovine Pericardium

Device Class : 2

Duns Number: 119253177

Premarket Exempt : No

Product Code : PSQ

Prescription Use : Yes

Device Count : 1

PhotoFix Decellularized Bovine Pericardium - 00877234000539 Catalog Number : PFP1X6

Device Description : Decellularized Bovine Pericardium

Device Class : 2

Duns Number: 119253177

Premarket Exempt : No

Product Code : PSQ

Prescription Use : Yes

Device Count : 1

PhotoFix Decellularized Bovine Pericardium - 00877234000546 Catalog Number : PFP4X4

Device Description : Decellularized Bovine Pericardium

Device Class : 2

Duns Number: 119253177

Premarket Exempt : No

Product Code : PSQ

Prescription Use : Yes

Device Count : 1

PhotoFix Decellularized Bovine Pericardium - 00877234000553 Catalog Number : PFP0.8X8

Device Description : Decellularized Bovine Pericardium

Device Class : 2

Duns Number: 119253177

Premarket Exempt : No

Product Code : PSQ

Prescription Use : Yes

Device Count : 1

PhotoFix Decellularized Bovine Pericardium - 00877234000560 Catalog Number : PFP8X14

Device Description : Decellularized Bovine Pericardium

Device Class : 2

Duns Number: 119253177

Premarket Exempt : No

Product Code : PSQ

Prescription Use : Yes

Device Count : 1

PhotoFix Decellularized Bovine Pericardium - 00877234000621 Catalog Number : PFP6X8

Device Description : Decellularized Bovine Pericardium

Device Class : 2

Duns Number: 119253177

Premarket Exempt : No

Product Code : PSQ

Prescription Use : Yes

Device Count : 1

PhotoFix Decellularized Bovine Pericardium - 00877234000638 Catalog Number : PFP1X10

Device Description : Decellularized Bovine Pericardium

Device Class : 2

Duns Number: 119253177

Premarket Exempt : No

Product Code : PSQ

Prescription Use : Yes

Device Count : 1

PhotoFix Decellularized Bovine Pericardium - 00877234000645 Catalog Number : PFP1X14

Device Description : Decellularized Bovine Pericardium

Device Class : 2

Duns Number: 119253177

Premarket Exempt : No

Product Code : PSQ

Prescription Use : Yes

Device Count : 1

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