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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Valeo Rod, ø5.5mm x 150mm, Straight
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555110071150 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 150 Millimeter
11.007.1150

  • Bone-screw internal spinal fixation system rod
Valeo Rod, ø5.5mm x 80mm, Straight
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555110071080 ()

  • Length: 80 Millimeter
  • Outer Diameter: 5.5 Millimeter
11.007.1080

  • Bone-screw internal spinal fixation system rod
Valeo Rod, ø5.5mm x 60mm, Straight
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555110071060 ()

  • Length: 60 Millimeter
  • Outer Diameter: 5.5 Millimeter
11.007.1060

  • Bone-screw internal spinal fixation system rod
Valeo PL,9x25, 0°, 15mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555110043015 ()

  • Length: 9 Millimeter
  • Width: 25 Millimeter
  • Height: 15 Millimeter
11.004.3015

  • Ceramic spinal interbody fusion cage
Valeo PL,9x25, 0°, 14mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555110043014 ()

  • Height: 14 Millimeter
  • Width: 25 Millimeter
  • Length: 9 Millimeter
11.004.3014

  • Ceramic spinal interbody fusion cage
Valeo PL,9x25, 0°, 13mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555110043013 ()

  • Length: 9 Millimeter
  • Width: 25 Millimeter
  • Height: 13 Millimeter
11.004.3013

  • Ceramic spinal interbody fusion cage
Valeo PL,9x25, 0°, 12mm
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555110043012 ()

  • Height: 12 Millimeter
  • Width: 25 Millimeter
  • Length: 9 Millimeter
11.004.3012

  • Vertebral body prosthesis
Valeo PL,9x25, 0°, 11mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555110043011 ()

  • Length: 9 Millimeter
  • Width: 25 Millimeter
  • Height: 11 Millimeter
11.004.3011

  • Ceramic spinal interbody fusion cage
Valeo PL,9x25, 0°, 10mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555110043010 ()

  • Height: 10 Millimeter
  • Width: 25 Millimeter
  • Length: 9 Millimeter
11.004.3010

  • Ceramic spinal interbody fusion cage
Valeo PL,9x25, 0°, 9mm
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555110043009 ()

  • Length: 9 Millimeter
  • Width: 25 Millimeter
  • Height: 9 Millimeter
11.004.3009

  • Vertebral body prosthesis
Valeo PL,9x25, 0°, 8mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555110043008 ()

  • Height: 8 Millimeter
  • Width: 25 Millimeter
  • Length: 9 Millimeter
11.004.3008

  • Ceramic spinal interbody fusion cage
Valeo PL,9x25, 0°, 7mm
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555110043007 ()

  • Length: 9 Millimeter
  • Width: 25 Millimeter
  • Height: 7 Millimeter
11.004.3007

  • Vertebral body prosthesis
Straight Rod 6.0mm, 600mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555102200600 ()

  • Length: 600 Millimeter
  • Outer Diameter: 6 Millimeter
10-2200-600

  • Bone-screw internal spinal fixation system rod
Straight Rod 6.0mm, 450mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555102200450 ()

  • Outer Diameter: 6 Millimeter
  • Length: 450 Millimeter
10-2200-450

  • Bone-screw internal spinal fixation system rod
Straight Rod 6.0mm, 350mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555102200350 ()

  • Length: 350 Millimeter
  • Outer Diameter: 6 Millimeter
10-2200-350

  • Bone-screw internal spinal fixation system rod
Straight Rod 6.0mm, 250mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555102200250 ()

  • Outer Diameter: 6 Millimeter
  • Length: 250 Millimeter
10-2200-250

  • Bone-screw internal spinal fixation system rod
Straight Rod 6.0mm, 150mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555102200150 ()

  • Length: 150 Millimeter
  • Outer Diameter: 6 Millimeter
10-2200-150

  • Bone-screw internal spinal fixation system rod
Straight Rod 6.0mm, 130mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555102200130 ()

  • Length: 130 Millimeter
  • Outer Diameter: 6 Millimeter
10-2200-130

  • Bone-screw internal spinal fixation system rod
Yttria stabilized zirconia disk
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724025246 ()

  • Width: 22 Millimeter
  • Outer Diameter: 94 Millimeter
MDDK3702ZF22

  • Dental appliance fabrication material, ceramic
Yttria stabilized Zirconia Disk
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022474 ()

  • Width: 20 Millimeter
  • Outer Diameter: 94 Millimeter
MDDK3702ZF20

  • Dental appliance fabrication material, ceramic
Yttria stabilized Zirconia Disk
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022467 ()

  • Width: 18 Millimeter
  • Outer Diameter: 94 Millimeter
MDDK3702ZF18

  • Dental appliance fabrication material, ceramic
Yttria stabilized Zirconia Disk
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022450 ()

  • Width: 16 Millimeter
  • Outer Diameter: 94 Millimeter
MDDK3702ZF16

  • Dental appliance fabrication material, ceramic
Yttria stabilized Zirconia Disk
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022443 ()
MDDK3702ZF14

  • Dental appliance fabrication material, ceramic
Yttria stabilized Zirconia
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022436 ()

  • Width: 12 Millimeter
  • Outer Diameter: 94 Millimeter
MDDK3702ZF12

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022429 ()

  • Outer Diameter: 95 Millimeter
  • Height: 18 Millimeter
MDDK3740Z18V2

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022245 ()

  • Height: 25 Millimeter
  • Outer Diameter: 95 Millimeter
MDDK3740Z25V1

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022238 ()

  • Outer Diameter: 95 Millimeter
  • Height: 22 Millimeter
MDDK3740Z22V1

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022221 ()

  • Height: 18 Millimeter
  • Outer Diameter: 95 Millimeter
MDDK3740Z18V1

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022214 ()

  • Outer Diameter: 95 Millimeter
  • Height: 16 Millimeter
MDDK3740Z16V6

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022207 ()

  • Height: 16 Millimeter
  • Outer Diameter: 95 Millimeter
MDDK3740Z16V5

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022191 ()

  • Outer Diameter: 95 Millimeter
  • Height: 16 Millimeter
MDDK3740Z16V4

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022184 ()

  • Height: 16 Millimeter
  • Outer Diameter: 95 Millimeter
MDDK3740Z16V3

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022177 ()

  • Outer Diameter: 95 Millimeter
  • Height: 16 Millimeter
MDDK3740Z16V2

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022160 ()

  • Height: 16 Millimeter
  • Outer Diameter: 95 Millimeter
MDDK3740Z16V1

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022153 ()

  • Outer Diameter: 95 Millimeter
  • Height: 16 Millimeter
MDDK3740Z16V0

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022146 ()

  • Height: 14 Millimeter
  • Outer Diameter: 95 Millimeter
MDDK3740Z14V6

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022139 ()

  • Outer Diameter: 95 Millimeter
  • Height: 14 Millimeter
MDDK3740Z14V5

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022122 ()

  • Height: 14 Millimeter
  • Outer Diameter: 95 Millimeter
MDDK3740Z14V4

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022115 ()

  • Outer Diameter: 95 Millimeter
  • Height: 14 Millimeter
MDDK3740Z14V3

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022108 ()

  • Height: 14 Millimeter
  • Outer Diameter: 95 Millimeter
MDDK3740Z14V2

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022092 ()

  • Outer Diameter: 95 Millimeter
  • Height: 14 Millimeter
MDDK3740Z14V1

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724022085 ()

  • Height: 14 Millimeter
  • Outer Diameter: 95 Millimeter
MDDK3740Z14V0

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724021521 ()

  • Height: 16 Millimeter
MDBL16ZS1000

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1400 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724021477 ()

  • Height: 16 Millimeter
MDBL16T1000

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724021149 ()

  • Outer Diameter: 98 Millimeter
  • Height: 18 Millimeter
MDDK3702ZS18V6

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724021132 ()

  • Height: 18 Millimeter
  • Outer Diameter: 98 Millimeter
MDDK3702ZS18V5

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724021125 ()

  • Outer Diameter: 98 Millimeter
  • Height: 18 Millimeter
MDDK3702ZS18V4

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724021118 ()

  • Height: 18 Millimeter
  • Outer Diameter: 98 Millimeter
MDDK3702ZS18V3

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724021101 ()

  • Outer Diameter: 98 Millimeter
  • Height: 18 Millimeter
MDDK3702ZS18V2

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
A
In Commercial Distribution

  • 00817724021095 ()

  • Height: 18 Millimeter
  • Outer Diameter: 98 Millimeter
MDDK3702ZS18V1

  • Dental appliance fabrication material, ceramic
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