Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code 1504026, 0.8x8cm, product code 1504028, 1x10cm, product code 1504030, and 2x9cm, product code 1504032. VASCU-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile. VASCU-GUARD is intended for use in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.
Product Code: 506005078050 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017 Product Code:506005078051 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017 Product Code:506005078052 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017 Product Code:506005078058 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017 Product Code:506005078060 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017 Product Code:506005078070 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017 Product Code:506005078072 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017
Worldwide Distribution: United States: Nationwide (including Puerto Rico) and countries of: Canada, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, Great Britain, Ireland, Italy, The Netherlands, Norway, Sweden, Slovenia, Czech Republic, Kuwait, Mexico, Brazil, Australia, Taiwan, and New Zealand.
Description du dispositif
Actifuse ABX/Actifuse MIS System || A bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure.
Distributed US (nationwide) including Puerto Rico and in the Bahamas, Canada, and Singapore.
Description du dispositif
COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
Distributed US (nationwide) including Puerto Rico and in the Bahamas, Canada, and Singapore.
Description du dispositif
COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
Distributed US (nationwide) including Puerto Rico and in the Bahamas, Canada, and Singapore.
Description du dispositif
COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
Nationwide including Puerto Rico, and outside the US to include: Australia, Austria, Finland, Germany, Greece, Ireland, Italy, the Netherlands, Norway, Poland, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, United Kingdom.
Description du dispositif
Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: || 1 cm x 6 cm, product code VG0106N, || 0.8 cm x 8 cm, product code VG0108N, || 1 cm x 10 cm, product code VG0110N, and || 2 cm x 9 cm, product code VG0209N. || VASC U-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. Sterilized using aseptic processing techniques. The pericardium is procured from cattle originating in the United States. VASC-Guard is chemically sterilized using ethanol and propylene oxide. || UPDATE 9/1/2016 Retrieval of devices only includes Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: || 1 cm x 6 cm, product code VG0106N, || 0.8 cm x 8 cm, product code VG0108N.