Synovis Peri-Strips Dry Series, Instructions For Use Manual, Page: 4 / 60

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DESCRIPTION:
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. Each PSD-V loading unit and each Gel tube is packaged sterile in a separate
pouch.
INDICATIONS FOR USE:
PSD-V is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers
when staple line reinforcement is needed.
PSD-V can be used for reinforcement of staple lines during lung and bronchus resections and during bariatric
surgical procedures.
PSD-V can be used for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and
colorectal procedures.
CONTRAINDICATIONS:
The use of PSD-V is contraindicated in patients with known sensitivity to bovine material.
ADVERSE REACTIONS:
As with any surgical procedure, adverse reactions are possible and include but are not limited to:
infection, rejection, erosion, and allergic reaction.
WARNINGS:
Do not re-sterilize. Resterilization may cause changes to the tissue and negatively impact
functionality of the device.
Discard all open unused components.
Do not use product if there is damage to the pouch or seals.
Ensure the staple line is completely covered with the buttress, or inadequate coverage after firing
may result.
SYMBOL DEFINITIONS:
Store at a controlled room temperature.
Keep away from heat. Do not use if heat indicator is red.
Do not reuse
Consult Instructions for Use
Sterile
Sterilized using ethylene oxide
Do not use if the product sterilization barrier or its packaging is compromised.
Sterilized using steam heat
This product is treated with sodium hydroxide.
This product is derived from USDA inspected cattle.
Made in the USA
CAUTION: Federal (USA) law restricts this device to sale by, or on the order
of, a physician.
Catalog number
Use by date
Lot number
Compatible stapler models
Remove before use
Manufacturer
SSI part number
SSI tracking number
SSI internal code
SSI internal code
REMOVE BEFORE USE