SYNOVIS LIFE TECHNOLOGIES, INC.

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- Catalog Number : VG0108N

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

- Catalog Number : VG0110N

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

- Catalog Number : VG0209N

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

- Catalog Number : DG0209SN

Device Description : Dura-Guard is prepared from bovine pericardium which is cross-linked with glutar Dura-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Dura-Guard is chemically sterilized using ethanol and propylene oxide. Dura-Guard has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C. Dura-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 : GXQ

Prescription Use : Yes

Device Count : 1

- Catalog Number : DG0404SN

Device Description : Dura-Guard is prepared from bovine pericardium which is cross-linked with glutar Dura-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Dura-Guard is chemically sterilized using ethanol and propylene oxide. Dura-Guard has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C. Dura-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 : GXQ

Prescription Use : Yes

Device Count : 1

- Catalog Number : DG0608SN

Device Description : Dura-Guard is prepared from bovine pericardium which is cross-linked with glutar Dura-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Dura-Guard is chemically sterilized using ethanol and propylene oxide. Dura-Guard has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C. Dura-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 : GXQ

Prescription Use : Yes

Device Count : 1

- Catalog Number : DG0814SN

Device Description : Dura-Guard is prepared from bovine pericardium which is cross-linked with glutar Dura-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Dura-Guard is chemically sterilized using ethanol and propylene oxide. Dura-Guard has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C. Dura-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 : GXQ

Prescription Use : Yes

Device Count : 1

- Catalog Number : DG1016SN

Device Description : Dura-Guard is prepared from bovine pericardium which is cross-linked with glutar Dura-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Dura-Guard is chemically sterilized using ethanol and propylene oxide. Dura-Guard has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C. Dura-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 : GXQ

Prescription Use : Yes

Device Count : 1

- Catalog Number : RM0208BIO

Device Description : Veritas® Collagen Matrix is an implantable biologic mesh comprised of noncrossli Veritas® Collagen Matrix is an implantable biologic mesh comprised of noncrosslinked bovine pericardium. Veritas Collagen Matrix bovine pericardium is sourced from cattle less than 30 months of age.

Device Class : 2

Duns Number: 017415781

Premarket Exempt : No

Product Code : PAJ, FTM, OXE, OXB, OWV

Prescription Use : Yes

Device Count : 1

- Catalog Number : RM0304BIO

Device Description : Veritas® Collagen Matrix is an implantable biologic mesh comprised of noncrossli Veritas® Collagen Matrix is an implantable biologic mesh comprised of noncrosslinked bovine pericardium. Veritas Collagen Matrix bovine pericardium is sourced from cattle less than 30 months of age.

Device Class : 2

Duns Number: 017415781

Premarket Exempt : No

Product Code : OWV, FTM, OXB, PAJ, OXE

Prescription Use : Yes

Device Count : 1