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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, Ta
Innovasis, Inc.
CH121406
In Commercial Distribution

  • M711CH1214061 ()
  • M711CH1214060 ()

  • Angle: 8 degree
  • Height: 6 Millimeter
  • Width: 14 Millimeter
  • Length: 12 Millimeter
CH121406

  • Polymeric 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
Scar and Laser Gel
IMPLANTECH ASSOCIATES, INC.
14 gram
In Commercial Distribution

  • M724CSG141 ()
  • M724CSG1412PK2 ()
CSG-14

  • Scar-management dressing, reusable
Scar and Laser Gel
IMPLANTECH ASSOCIATES, INC.
5 gram
In Commercial Distribution

  • M724CSG051 ()
  • M724CSG0512PK2 ()
CSG-05

  • Scar-management dressing, reusable
No Description
OPHTHALMED LLC
B62B513
Not in Commercial Distribution

  • M735B62B5135 ()
  • M735B62B5131 ()

  • Needle Gauge: 23 Gauge


  • Ophthalmic laser system beam guide
No Description
OPHTHALMED LLC
B62B413
Not in Commercial Distribution

  • M735B62B4135 ()
  • M735B62B4131 ()

  • Needle Gauge: 23 Gauge


  • Ophthalmic laser system beam guide
No Description
OPHTHALMED LLC
B62B313
Not in Commercial Distribution

  • M735B62B3135 ()
  • M735B62B3131 ()

  • Needle Gauge: 23 Gauge


  • Ophthalmic laser system beam guide
No Description
OPHTHALMED LLC
B62B213
Not in Commercial Distribution

  • M735B62B2135 ()
  • M735B62B2131 ()

  • Needle Gauge: 23 Gauge


  • Ophthalmic laser system beam guide
No Description
OPHTHALMED LLC
B62B113
Not in Commercial Distribution

  • M735B62B1135 ()
  • M735B62B1131 ()

  • Needle Gauge: 23 Gauge


  • Ophthalmic laser system beam guide
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