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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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The universal joint is made from stainless steel. It is used to aid in the assembly of the Integra External Fixation System.
Ascension Orthopedics, Inc.
12225221
In Commercial Distribution

  • 10381780125433 ()

  • 1.28 in L
12225221

  • External orthopaedic fixation system, reusable
The extended compression distraction nut is manufactured from stainless steel and is used to secure components in the Integra External Fixation System.
Ascension Orthopedics, Inc.
12224216
In Commercial Distribution

  • 10381780125136 ()

  • .59 in H x .394 in top dia
12224216

  • External orthopaedic fixation system, reusable
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.
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.
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.
PC0404N
In Commercial Distribution

  • 00085412530529 ()
PC0404NBIO

  • Cardiovascular patch, animal-derived
The L-Varlock is a lumbar cage, for intervertebral body fusion.
SPINESOURCE INC
165
In Commercial Distribution

  • 00850011324165 ()

  • Height: 11 Millimeter
  • Width: 13 Millimeter
VAL-CA-13-11

  • Metallic spinal interbody fusion cage
The L-Varlock is a lumbar cage, for intervertebral body fusion.
SPINESOURCE INC
158
In Commercial Distribution

  • 00850011324158 ()

  • Height: 9 Millimeter
  • Width: 13 Millimeter
VAL-CA-13-09

  • Metallic spinal interbody fusion cage
The L-Varlock is a lumbar cage, for intervertebral body fusion.
SPINESOURCE INC
134
In Commercial Distribution

  • 00850011324134 ()

  • Height: 13 Millimeter
  • Width: 13 Millimeter
VAL-CA-13-13

  • Metallic spinal interbody fusion cage
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