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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STRAIGHT LUMBAR CAGE, L 25mm, W 11mm, H 8 mm, A 0-DEG
INFRONT MEDICAL LLC
003-BB08
In Commercial Distribution

  • B116003BB081 ()

  • Length: 28 Millimeter
003-BB08

  • Polymeric spinal interbody fusion cage
STRAIGHT LUMBAR CAGE, L 22mm, W 11mm, H 7 mm, A 0-DEG
INFRONT MEDICAL LLC
003-AB07
In Commercial Distribution

  • B116003AB071 ()

  • Length: 28 Millimeter
003-AB07

  • Polymeric spinal interbody fusion cage
Intramedullary And Accessories
Epix Orthopaedics Inc.
3210-28010L
In Commercial Distribution

  • B221321028010L1 ()

  • Length: 28 Millimeter
3210-28010L

  • Flexible bone nail
Semi-rigid Uretero Renoscope 6.0/7.5 Fr. 5 deg., direct/straight view, L=430 mm, autoclavable
INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C.
30-0646-00
In Commercial Distribution

  • B192300646000 ()

  • Catheter Gauge: 6.0 French
  • Angle: 5 degree
  • Catheter Gauge: 7.5 French
  • Length: 430 Millimeter
30-0646-00

  • Rigid optical ureteroscope
ELEOS Collar Sizing Gauge, 28mm
ONKOS SURGICAL, INC.
HB-GAG28-03N
In Commercial Distribution

  • B278HBGAG2803N0 ()

  • Length: 28 Millimeter
HB-GAG28-03N

  • Orthopaedic prosthesis implantation positioning instrument, reusable
WHT PEARL CERV PLATE, 2-LEVEL, 28mm, CANN, PREF ACP
Osseus Fusion Systems, LLC
2100-2128
In Commercial Distribution

  • B06221002128 ()

  • Length: 28 Millimeter
  • Width: 17.5 Millimeter
2100-2128

  • Metallic spinal interbody fusion cage
2-2, 28mm plate, standard
CAMBER SPINE TECHNOLOGIES, LLC
FCP-2528
In Commercial Distribution

  • B030FCP25280 ()

  • Width: 16 Millimeter
  • Depth: 2 Millimeter
  • Length: 28 Millimeter


  • Spinal fixation plate, non-bioabsorbable
2-1, 28mm plate, standard
CAMBER SPINE TECHNOLOGIES, LLC
FCP-2428
In Commercial Distribution

  • B030FCP24280 ()

  • Length: 28 Millimeter
  • Width: 16 Millimeter
  • Depth: 2 Millimeter


  • Spinal fixation plate, non-bioabsorbable
1-1, 28mm plate, standard
CAMBER SPINE TECHNOLOGIES, LLC
FCP-2328
In Commercial Distribution

  • B030FCP23280 ()

  • Length: 28 Millimeter
  • Width: 16 Millimeter
  • Depth: 2 Millimeter


  • Spinal fixation plate, non-bioabsorbable
Cortical Screw, 28mm
Orthopedic Designs North America, Inc.
THS045028
In Commercial Distribution

  • B058THS0450281 ()

  • Length: 28 Millimeter
  • Outer Diameter: 4.5 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
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