SYNOVIS LIFE TECHNOLOGIES, INC.

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Device Description : Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement (PSD-V) is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the United States. The packaging contains a buttress assembly with two (2) circular buttresses, one for the anvil and one for the cartridge side of the stapler.

Device Class : 2

Duns Number: 017415781

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

Device Description : Peri-Strips Dry with Veritas Collagen Matrix (PSD-V) Circular Staple Line Reinfo Peri-Strips Dry with Veritas Collagen Matrix (PSD-V) Circular Staple Line Reinforcement is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the United States. The packaging contains two loading units w/buttress material, one for the anvil and one for the cartridge side of the stapler. The packaging also includes one cartridge cone to aid atraumatic advancement of the stapler into the surgical site, and one tube of PSD Gel to create a temporary bond between the buttress and the surgical stapler until the stapler is positioned and fired.

Device Class : 2

Duns Number: 017415781

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

Device Description : Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement (PSD-V) is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the United States. The packaging contains a buttress assembly with two (2) circular buttresses, one for the anvil and one for the cartridge side of the stapler. Each buttress assembly has a coating of acrylic adhesive on one side for attachment to the stapler surfaces. The packaging also includes one cartridge cone to aid atraumatic advancement of the stapler into the surgical site.

Device Class : 2

Duns Number: 017415781

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

- Catalog Number : PSDGel3pkwTips

Device Description : PSD Gel is prepared from Hydroxypropyl Methyl Cellulose, Propylene Glycol, and w PSD Gel is prepared from Hydroxypropyl Methyl Cellulose, Propylene Glycol, and water. The PSD Gel is used to bond the Peri-Strips Dry pericardium strips onto the surgical stapler forks until the stapler is positioned and fired.

Device Class : 2

Duns Number: 017415781

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

Device Description : Peri-Strips Dry with Veritas Collagen Matrix (PSD-V) is prepared from dehydrated Peri-Strips Dry with Veritas Collagen Matrix (PSD-V) is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the United States. One (1) tube of PSD Gel (Gel) is provided for every two (2) pouches of PSD-V. The Gel is used to create a temporary bond between the PSD-V buttress and the surgical stapler jaws until the stapler is positioned and fired.

Device Class : 2

Duns Number: 017415781

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

Device Description : Peri-Strips Dry with Veritas Collagen Matrix (PSD-V) is prepared from dehydrated Peri-Strips Dry with Veritas Collagen Matrix (PSD-V) is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the United States. One (1) tube of PSD Gel (Gel) is provided for every two (2) pouches of PSD-V. The Gel is used to create a temporary bond between the PSD-V buttress and the surgical stapler jaws until the stapler is positioned and fired.

Device Class : 2

Duns Number: 017415781

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

Device Description : Peri-Strips Dry with Veritas Collagen Matrix (PSD-V) is prepared from dehydrated Peri-Strips Dry with Veritas Collagen Matrix (PSD-V) is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the United States. One (1) tube of PSD Gel (Gel) is provided for every two (2) pouches of PSD-V. The Gel is used to create a temporary bond between the PSD-V buttress and the surgical stapler jaws until the stapler is positioned and fired.

Device Class : 2

Duns Number: 017415781

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

Device Description : Peri-Strips Dry with Veritas Collagen Matrix (PSD-V) is prepared from dehydrated Peri-Strips Dry with Veritas Collagen Matrix (PSD-V) is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the United States. One (1) tube of PSD Gel (Gel) is provided for every two (2) pouches of PSD-V. The Gel is used to create a temporary bond between the PSD-V buttress and the surgical stapler jaws until the stapler is positioned and fired.

Device Class : 2

Duns Number: 017415781

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

Device Description : Peri-Strips Dry with Veritas Collagen Matrix (PSD-V) is prepared from dehydrated Peri-Strips Dry with Veritas Collagen Matrix (PSD-V) is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the United States. One (1) tube of PSD Gel (Gel) is provided for every two (2) pouches of PSD-V. The Gel is used to create a temporary bond between the PSD-V buttress and the surgical stapler jaws until the stapler is positioned and fired.

Device Class : 2

Duns Number: 017415781

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

Device Description : Peri-Strips Dry with Veritas Collagen Matrix (PSD-V) is prepared from dehydrated Peri-Strips Dry with Veritas Collagen Matrix (PSD-V) is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the United States. One (1) tube of PSD Gel (Gel) is provided for every two (2) pouches of PSD-V. The Gel is used to create a temporary bond between the PSD-V buttress and the surgical stapler jaws until the stapler is positioned and fired.

Device Class : 2

Duns Number: 017415781

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1