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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LEEP PRECISION™ Smoke Evacuation (120 VAC)
Coopersurgical, Inc.
53502
In Commercial Distribution

  • 00888937014327 ()


  • Surgical plume evacuation system
The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. The Kodiak Lumbar Spacer System may be implanted bilaterally using a posterior (PLIF) approach, or as a single device employing a transformational (TLIF) approach. The implants have a central endplate window to permit packing of autograft and/or allograft bone, teeth on the superior and inferior surfaces, and lateral windows for radiographic visualization. The implants are additively manufactured from Ti-6Al-4V ELI and are available in a variety of heights, footprints, and lordotic configurations to suit individual patient anatomy.
MET 1 TECHNOLOGIES, LLC
04-07G
In Commercial Distribution

  • 00819824028691 ()
04-07G

  • Bone graft packing block
Powered walking assistance device
B-Temia Inc
5062601
In Commercial Distribution

  • 07540162060007 ()


  • Programmable ambulation exoskeleton, clinical
Base
SpineArt SA
JLL-IN 44 00-N
In Commercial Distribution

  • 07640185342989 ()
JLL-IN 44 00-N

  • Bone graft packing block
COMPACTION BASE
SpineArt SA
JLL-IN 08 01-N
In Commercial Distribution

  • 07640178982765 ()
JLL-IN 08 01-N

  • Bone graft packing block
Compaction base
SpineArt SA
DYN-IP 01 03-N
In Commercial Distribution

  • 07640139349941 ()
DYN-IP 01 03-N

  • Bone graft packing block
Compaction base
SpineArt SA
DYN-IT 00 03-N
In Commercial Distribution

  • 07640139342881 ()
DYN-IT 00 03-N

  • Bone graft packing block
Compaction base
SpineArt SA
DYN-IP 00 03-N
In Commercial Distribution

  • 07640139342423 ()
DYN-IP 00 03-N

  • Bone graft packing block
Compactor
SpineArt SA
DYN-IP 00 02-N
In Commercial Distribution

  • 07640139342416 ()
DYN-IP 00 02-N

  • Bone graft packing block
JBAIDS IVD Influenza A Subtyping Kit
BIOFIRE DEFENSE, LLC
JRPD-ASY-0138
Not in Commercial Distribution

  • 00851458005075 ()
JRPD-ASY-0138

  • Influenza A virus H5N1 subtype (avian influenza) nucleic acid IVD, kit, nucleic acid technique (NAT)
The Integra Sphenoidal Electrode is designed for investigative intraoperative monitoring of cortical electrical activity specifically at the undersurface of the temporal lobe. It has one platinum contact and is supplied with an insertion needle.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
EDSEP
Not in Commercial Distribution

  • M272EDSEP1 ()
  • 10381780037088 ()


  • Depth electrode
The Integra Sphenoidal Electrode is designed for investigative intraoperative monitoring of cortical electrical activity specifically at the undersurface of the temporal lobe. It has one platinum contact and is supplied with an insertion needle.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
40M08
Not in Commercial Distribution

  • M27240M081 ()
  • 10381780034766 ()

  • Insertion needle 64mm Length


  • Depth electrode
Hemashield Woven Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000196270
In Commercial Distribution

  • 00384401018827 ()

  • Length: 15.2 Centimeter
  • Width: 5.1 Centimeter
M002000196270

  • Cardiovascular patch, animal-derived
Hemashield Woven Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000196240
In Commercial Distribution

  • 00384401018810 ()

  • Length: 7.6 Centimeter
  • Width: 5.1 Centimeter
M002000196240

  • Cardiovascular patch, animal-derived
Hemashield Woven Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000196170
In Commercial Distribution

  • 00384401018803 ()

  • Length: 152 Millimeter
  • Width: 25 Millimeter
M002000196170

  • Cardiovascular patch, animal-derived
Hemashield Platinum Finesse Ultra-Thin Knitted Cardiovascular Patch
INTERVASCULAR SAS
M00202019561P0
In Commercial Distribution

  • 00384401017981 ()

  • Length: 15.2 Centimeter
  • Width: 2.5 Centimeter
M00202019561P0

  • Cardiovascular patch, animal-derived
Hemashield Platinum Finesse Ultra-Thin Knitted Cardiovascular Patch
INTERVASCULAR SAS
M00202019530P0
In Commercial Distribution

  • 00384401017974 ()

  • Length: 7.6 Centimeter
  • Width: 2.5 Centimeter
M00202019530P0

  • Cardiovascular patch, animal-derived
Hemashield Platinum Finesse Ultra-Thin Knitted Cardiovascular Patch
INTERVASCULAR SAS
M00202019585P0
In Commercial Distribution

  • 00384401017967 ()

  • Length: 15.2 Centimeter
  • Width: 0.8 Centimeter
M00202019585P0

  • Cardiovascular patch, animal-derived
Hemashield Platinum Finesse Ultra-Thin Knitted Cardiovascular Patch
INTERVASCULAR SAS
M00202019579P0
In Commercial Distribution

  • 00384401017950 ()

  • Length: 7.6 Centimeter
  • Width: 0.8 Centimeter
M00202019579P0

  • Cardiovascular patch, animal-derived
Hemashield Platinum Finesse Ultra-Thin Knitted Cardiovascular Patch
INTERVASCULAR SAS
M00202019575P0
In Commercial Distribution

  • 00384401017943 ()

  • Length: 7.6 Centimeter
  • Width: 0.6 Centimeter
M00202019575P0

  • Cardiovascular patch, animal-derived
Hemashield Knitted Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000195270
In Commercial Distribution

  • 00384401017936 ()

  • Length: 15.2 Centimeter
  • Width: 5.1 Centimeter
M002000195270

  • Cardiovascular patch, animal-derived
Hemashield Knitted Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000195240
In Commercial Distribution

  • 00384401017929 ()

  • Length: 7.6 Centimeter
  • Width: 5.1 Centimeter
M002000195240

  • Cardiovascular patch, animal-derived
Hemashield Knitted Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000195170
In Commercial Distribution

  • 00384401017912 ()

  • Length: 15.2 Centimeter
  • Width: 2.5 Centimeter
M002000195170

  • Cardiovascular patch, animal-derived
Hemashield Knitted Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000195090
In Commercial Distribution

  • 00384401017905 ()

  • Length: 7.6 Centimeter
  • Width: 0.8 Centimeter
M002000195090

  • Cardiovascular patch, animal-derived
Hemashield Knitted Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000195140
In Commercial Distribution

  • 00384401017899 ()

  • Length: 7.6 Centimeter
  • Width: 2.5 Centimeter
M002000195140

  • Cardiovascular patch, animal-derived
Hemashield Knitted Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000195100
In Commercial Distribution

  • 00384401017882 ()

  • Length: 15.2 Centimeter
  • Width: 0.8 Centimeter
M002000195100

  • Cardiovascular patch, animal-derived
Hemashield Knitted Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000195290
In Commercial Distribution

  • 00384401017875 ()

  • Length: 7.6 Centimeter
  • Width: 0.8 Centimeter
M002000195290

  • Cardiovascular patch, animal-derived
Hemashield Knitted Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000195280
In Commercial Distribution

  • 00384401017868 ()

  • Length: 12.0 Centimeter
  • Width: 0.6 Centimeter
M002000195280

  • Cardiovascular patch, animal-derived
Hemashield Knitted Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000195250
In Commercial Distribution

  • 00384401017851 ()

  • Length: 7.6 Centimeter
  • Width: 0.6 Centimeter
M002000195250

  • Cardiovascular patch, animal-derived
Hemapatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK20/140P (1)
In Commercial Distribution

  • 00384401010654 ()

  • Width: 20 Millimeter
  • Length: 140 Millimeter
HEK20/140P (1)

  • Cardiovascular patch, animal-derived
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