Symbol Definitions; Contraindications - Synovis Peri-Guard Mode D'emploi

SYMBOL DEFINITIONS:

Do not freeze
Lower limit of temperature
0ºC/32ºF
Do not reuse
Consult Instructions for Use
Sterilized using aseptic processing techniques
This product is treated with sodium hydroxide
This product is derived from U.S.D.A.-inspected cattle
Made in the U.S.A.
CAUTION: Federal (U.S.A.) Law restricts this device
to sale by or on the order of a physician
CONTENT Content
Catalog number
Use by date
Lot number
Manufacturer
Authorized Representative in the European Community
SSI part number SSI internal code
INDICATIONS:
For use as a prosthesis for pericardial closure and soft tissue deficiencies
which include: defects of the abdominal and thoracic wall, hernias
(diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal
and umbilical), and intracardiac and great vessel repair.
DESCRIPTION:
®
Peri-Guard is prepared from bovine pericardium which is cross-linked
with glutaraldehyde. The pericardium is procured from cattle originating
in the United States. Peri-Guard is chemically sterilized using
glutaraldehyde, ethanol, and propylene oxide. Peri-Guard has been treated
with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C.
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.

CONTRAINDICATIONS:

Peri-Guard is not designed, sold or intended for use except as indicated.
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