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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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HA PEEK, Tantalum, Ti 6Al 4V ELI
Innovasis, Inc.
AX104008
In Commercial Distribution

  • M711AX1040081 ()
  • M711AX1040080 ()

  • Height: 10 Millimeter
  • Width: 40 Millimeter
  • Angle: 8 degree


  • Metal-polymer composite spinal interbody fusion cage
HA PEEK, Tantalum, Ti 6Al 4V ELI
Innovasis, Inc.
AX103614
In Commercial Distribution

  • M711AX1036141 ()
  • M711AX1036140 ()

  • Angle: 14 degree
  • Width: 36 Millimeter
  • Height: 10 Millimeter


  • Metal-polymer composite spinal interbody fusion cage
HA PEEK, Tantalum, Ti 6Al 4V ELI
Innovasis, Inc.
AX103608
In Commercial Distribution

  • M711AX1036081 ()
  • M711AX1036080 ()

  • Height: 10 Millimeter
  • Width: 36 Millimeter
  • Angle: 8 degree


  • Metal-polymer composite spinal interbody fusion cage
HA PEEK, Tantalum, Ti 6Al 4V ELI
Innovasis, Inc.
AX103014
In Commercial Distribution

  • M711AX1030141 ()
  • M711AX1030140 ()

  • Angle: 14 degree
  • Width: 30 Millimeter
  • Height: 10 Millimeter


  • Metal-polymer composite spinal interbody fusion cage
HA PEEK, Tantalum, Ti 6Al 4V (ELI)
Innovasis, Inc.
AX103008
In Commercial Distribution

  • M711AX1030081 ()
  • M711AX1030080 ()

  • Height: 10 Millimeter
  • Width: 30 Millimeter
  • Angle: 8 degree


  • Metal-polymer composite spinal interbody fusion cage
Durashield® 5% Sodium Fluoride Varnish, Bubble Fun® 200 units of 0.40mL
Sultan Healthcare Inc
AD31102
Not in Commercial Distribution

  • D687AD311022 ()
  • D687AD311021 ()
  • D687AD311020 ()

  • Total Volume: 0.4 Milliliter


  • Dental cavity varnish
Durashield® 5% Sodium Fluoride Varnish, Bubble Fun® 32 units of 0.40mL
Sultan Healthcare Inc
AD31101
Not in Commercial Distribution

  • D687AD311012 ()
  • D687AD311011 ()
  • D687AD311010 ()

  • Total Volume: 0.4 Milliliter


  • Dental cavity varnish
HAtetracell-C, 16L x 19W x 12H x 12°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
65-16191212
In Commercial Distribution

  • M71165161912121 ()
  • M71165161912120 ()

  • Length: 16 Millimeter
  • Height: 12 Millimeter
  • Angle: 12 degree
  • Width: 19 Millimeter


  • Metallic spinal interbody fusion cage
HAtetracell-C, 16L x 19W x 12H x 8°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
65-16191208
In Commercial Distribution

  • M71165161912081 ()
  • M71165161912080 ()

  • Length: 16 Millimeter
  • Height: 12 Millimeter
  • Angle: 8 degree
  • Width: 19 Millimeter


  • Metallic spinal interbody fusion cage
HAtetracell-C, 16L x 19W x 11H x 12°, Ti 6Al 4V (ELI), HA
Innovasis, Inc.
65-16191112
In Commercial Distribution

  • M71165161911121 ()
  • M71165161911120 ()

  • Length: 16 Millimeter
  • Height: 11 Millimeter
  • Angle: 12 degree
  • Width: 19 Millimeter


  • Metallic spinal interbody fusion cage
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