SYNOVIS LIFE TECHNOLOGIES, INC.

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- Catalog Number : PC0404NBIO

Device Description : Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine p Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C.

Device Class : 2

Duns Number: 017415781

Premarket Exempt : No

Product Code : DXZ, FTM, OXB, OWV

Prescription Use : Yes

Device Count : 1

- Catalog Number : PC0608NBIO

Device Description : Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine p Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C.

Device Class : 2

Duns Number: 017415781

Premarket Exempt : No

Product Code : FTM, DXZ, OXB, OWV

Prescription Use : Yes

Device Count : 1

- Catalog Number : PC0814NBIO

Device Description : Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine p Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C.

Device Class : 2

Duns Number: 017415781

Premarket Exempt : No

Product Code : FTM, OXB, DXZ, OWV

Prescription Use : Yes

Device Count : 1

- Catalog Number : PC1016NBIO

Device Description : Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine p Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C.

Device Class : 2

Duns Number: 017415781

Premarket Exempt : No

Product Code : FTM, OWV, DXZ, OXB

Prescription Use : Yes

Device Count : 1

- Catalog Number : PC1225NBIO

Device Description : Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine p Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C.

Device Class : 2

Duns Number: 017415781

Premarket Exempt : No

Product Code : OXB, FTM, DXZ, OWV

Prescription Use : Yes

Device Count : 1

- Catalog Number : PC0404SNBIO

Device Description : Supple Peri-Guard is prepared from bovine pericardium which is cross-linked with Supple Peri-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Supple Peri-Guard is chemically sterilized using ethanol and propylene oxide. Supple Peri-Guard has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C. Supple Peri-Guard is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile

Device Class : 2

Duns Number: 017415781

Premarket Exempt : No

Product Code : FTM, DXZ, OWV, OXB

Prescription Use : Yes

Device Count : 1

- Catalog Number : PC0608SNBIO

Device Description : Supple Peri-Guard is prepared from bovine pericardium which is cross-linked with Supple Peri-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Supple Peri-Guard is chemically sterilized using ethanol and propylene oxide. Supple Peri-Guard has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C. Supple Peri-Guard is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile

Device Class : 2

Duns Number: 017415781

Premarket Exempt : No

Product Code : OWV, OXB, FTM, DXZ

Prescription Use : Yes

Device Count : 1

- Catalog Number : PC0814SNBIO

Device Description : Supple Peri-Guard is prepared from bovine pericardium which is cross-linked with Supple Peri-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Supple Peri-Guard is chemically sterilized using ethanol and propylene oxide. Supple Peri-Guard has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C. Supple Peri-Guard is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile

Device Class : 2

Duns Number: 017415781

Premarket Exempt : No

Product Code : DXZ, OXB, FTM, OWV

Prescription Use : Yes

Device Count : 1

- Catalog Number : PC1016SNBIO

Device Description : Supple Peri-Guard is prepared from bovine pericardium which is cross-linked with Supple Peri-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Supple Peri-Guard is chemically sterilized using ethanol and propylene oxide. Supple Peri-Guard has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C. Supple Peri-Guard is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile

Device Class : 2

Duns Number: 017415781

Premarket Exempt : No

Product Code : OWV, DXZ, FTM, OXB

Prescription Use : Yes

Device Count : 1

- Catalog Number : VG0106N

Device Description : Vascu-Guard is prepared from bovine pericardium which is cross-linked with gluta Vascu-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Vascu-Guard is chemically sterilized using ethanol and propylene oxide. Vascu-Guard has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C. Vascu-Guard is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile

Device Class : 2

Duns Number: 017415781

Premarket Exempt : No

Product Code : DXZ

Prescription Use : Yes

Device Count : 1