Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC1225N
In Commercial Distribution

  • 00085412530628 ()
PC1225NBIO

  • Cardiovascular patch, animal-derived
Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC1016N
In Commercial Distribution

  • 00085412530604 ()
PC1016NBIO

  • Cardiovascular patch, animal-derived
Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC0814N
In Commercial Distribution

  • 00085412530581 ()
PC0814NBIO

  • Cardiovascular patch, animal-derived
Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC0608N
In Commercial Distribution

  • 00085412530567 ()
PC0608NBIO

  • Cardiovascular patch, animal-derived
Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC0404N
In Commercial Distribution

  • 00085412530529 ()
PC0404NBIO

  • Cardiovascular patch, animal-derived
SafeAir Compact Smoke Evacuator
STRYKER CORPORATION
0703-045-000
In Commercial Distribution

  • 07613327466249 ()
0703-045-000

  • Surgical plume evacuation system
7 m Extension Tubing
STRYKER CORPORATION
0703-045-003
In Commercial Distribution

  • 07613327504125 ()
0703-045-003

  • Surgical plume evacuation system
Grounding Cable
STRYKER CORPORATION
0703-045-002
In Commercial Distribution

  • 07613327504118 ()
0703-045-002

  • Surgical plume evacuation system
The HarmonyAIR Smoke Evacuator Remote Switch Activator (RSA) is used with the HarmonyAIR Smoke Evacuation System.
STERIS CORPORATION
Smoke Evacuator Remote Switch Activator
Not in Commercial Distribution

  • 00724995150129 ()
QS0028

  • Surgical plume evacuation system
The HarmonyAIR Large Shelf 110V Smoke Evacuation System is designed to remove smoke, filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures.
STERIS CORPORATION
Smoke Evacuation System
In Commercial Distribution

  • 00724995150044 ()
QS0020

  • Surgical plume evacuation system
The HarmonyAIR Small Shelf 110V Smoke Evacuation System is designed to remove smoke, filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures.
STERIS CORPORATION
Smoke Evacuation System
In Commercial Distribution

  • 00724995150020 ()
QS0018

  • Surgical plume evacuation system
Pericardial Patch
ST. JUDE MEDICAL, INC.
C0405
In Commercial Distribution

  • 05414734054881 ()

  • Length: 5 Centimeter
  • Width: 4 Centimeter
C0405

  • Cardiovascular patch, animal-derived
With EnCap Technology
ST. JUDE MEDICAL, INC.
C0914
In Commercial Distribution

  • 05414734007276 ()

  • Length: 14 Centimeter
  • Width: 9 Centimeter
C0914

  • Cardiovascular patch, animal-derived
With EnCap Technology
ST. JUDE MEDICAL, INC.
C0510
In Commercial Distribution

  • 05414734007269 ()

  • Length: 10 Centimeter
  • Width: 5 Centimeter
C0510

  • Cardiovascular patch, animal-derived
With EnCap Technology
ST. JUDE MEDICAL, INC.
C0205
In Commercial Distribution

  • 05414734007252 ()

  • Width: 2 Centimeter
  • Length: 5 Centimeter
C0205

  • Cardiovascular patch, animal-derived
Smoke evacuation system 220V for Ergon 2 and 3, includes pneumatic foot switch. Requires H8-300-41-A mounting bracket. AIR SAFE filters required and QUIKLINK automatic activation device sold separately.
SKYTRON LLC
ELVV220
In Commercial Distribution

  • 10841736114992 ()


  • Surgical plume evacuation system
Smoke Evacuation System for Models Ergon 2 and 3, includes pneumatic foot switch. Requires H8-300-41-A mounting bracket. AIR SAFE filters and QUIKLINK automatic activation device sold separately.
SKYTRON LLC
SMOKE-E-VAC
In Commercial Distribution

  • 10841736100810 ()
SMOKE-E-VAC

  • Surgical plume evacuation system
Automatic activation device for Smoke-e-vac
SKYTRON LLC
QUIKLINK
In Commercial Distribution

  • 10841736100773 ()
QUIKLINK

  • Surgical plume evacuation system
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-36-0004
In Commercial Distribution

  • 09348215039905 ()


  • Instrument tray, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-001
In Commercial Distribution

  • 09348215039882 ()


  • Instrument tray, reusable
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