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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ALIF SA Graft Bolt, Ø8.5 x 35 mm
ALPHATEC SPINE, INC.
232-13-85-350
In Commercial Distribution

  • 00190376535128 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 35 Millimeter


  • Metallic spinal interbody fusion cage
ALIF SA Graft Bolt, Ø8 x 35 mm
ALPHATEC SPINE, INC.
232-13-80-350
In Commercial Distribution

  • 00190376535043 ()

  • Outer Diameter: 8 Millimeter
  • Length: 35 Millimeter


  • Metallic spinal interbody fusion cage
Flexitron Transfer Tube Set for 6F Flexibles (35)
Nucletron B.V.
137174-03
In Commercial Distribution

  • 08717213028081 ()


  • Brachytherapy system remote afterloading source transfer tube
Lateral Core Graft Bolt, 6.0 x 35 mm
ALPHATEC SPINE, INC.
612-60-35-C
In Commercial Distribution

  • 00190376525853 ()


  • Spinal bone screw, non-bioabsorbable
Lateral Core Graft Bolt, 5.5 x 35 mm
ALPHATEC SPINE, INC.
612-55-35-C
In Commercial Distribution

  • 00190376525761 ()


  • Spinal bone screw, non-bioabsorbable
Maestro .022 LR6 Std Buccal Tube Tempra 35
ORTHO ORGANIZERS, INC.
902-35108E-35
In Commercial Distribution

  • 00190707138523 ()


  • Orthodontic metal band
Elite.022 LL6 Conv Dbl BuccalTube Tempra 35
ORTHO ORGANIZERS, INC.
900-12408E-35
In Commercial Distribution

  • 00190707135201 ()


  • Orthodontic metal band
Maestro .022 LL6 Std Buccal Tube Tempra 35
ORTHO ORGANIZERS, INC.
902-35208E-35
In Commercial Distribution

  • 00190707138721 ()


  • Orthodontic metal band
Maestro .022 UL6 Std Buccal Tube Tempra 35
ORTHO ORGANIZERS, INC.
902-30408E-35
In Commercial Distribution

  • 00190707138233 ()


  • Orthodontic metal band
Maestro .022 UR6 Std Buccal Tube Tempra 35
ORTHO ORGANIZERS, INC.
902-30308E-35
In Commercial Distribution

  • 00190707137939 ()


  • Orthodontic metal band
TruFlex Copper 35 Full 018 Up 10/pk
ORTHO TECHNOLOGY, INC.
2007-111
Not in Commercial Distribution

  • 00190730020758 ()


  • Orthodontic archwire
TruFlex Copper 35 Full 016 Up 10/pk
ORTHO TECHNOLOGY, INC.
2007-110
Not in Commercial Distribution

  • 00190730020741 ()


  • Orthodontic archwire
TruFlex Copper 35 Euro 018 Lo 10/pk
ORTHO TECHNOLOGY, INC.
2008-211
In Commercial Distribution

  • 00190730021267 ()


  • Orthodontic archwire
TruFlex Copper 35 Euro 016 Lo 10/pk
ORTHO TECHNOLOGY, INC.
2008-210
In Commercial Distribution

  • 00190730021250 ()


  • Orthodontic archwire
TruFlex Copper 35 Euro 018 Up 10/pk
ORTHO TECHNOLOGY, INC.
2008-111
In Commercial Distribution

  • 00190730021090 ()


  • Orthodontic archwire
TruFlex Copper 35 Euro 016 Up 10/pk
ORTHO TECHNOLOGY, INC.
2008-110
Not in Commercial Distribution

  • 00190730021083 ()


  • Orthodontic archwire
TruFlex Copper 35 Full 018 Lo 10/pk
ORTHO TECHNOLOGY, INC.
2007-211
In Commercial Distribution

  • 00190730020925 ()


  • Orthodontic archwire
TruFlex Copper 35 Full 016 Lo 10/pk
ORTHO TECHNOLOGY, INC.
2007-210
Not in Commercial Distribution

  • 00190730020918 ()


  • Orthodontic archwire
RODLINK B TYPE, STROKE 35~41mm, Length 46mm
Corentec Co., Ltd
SP.C52.0035
In Commercial Distribution

  • 08800017242200 ()


  • Bone-screw internal spinal fixation system connector
35" Self AdjustMatt w/RR and pump-P/L
Drive Devilbiss Healthcare
AS-BA9600-P-RR
Not in Commercial Distribution

  • 00822383981635 ()


  • Flotation therapy bed, adult
35" Self Adjust Air/Foam w/pump-P/L
Drive Devilbiss Healthcare
AS-BA9600-P
Not in Commercial Distribution

  • 00822383981628 ()


  • Alternating-pressure inflator
Diameter 8.5 mm x 35 mm Monoaxial Screw
Ortho Development Corporation
752-8535-31
Not in Commercial Distribution

  • 00822409029594 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 35 Millimeter


  • Spinal bone screw, non-bioabsorbable
Diameter 8.5 mm x 35 mm Polyaxial Screw
Ortho Development Corporation
752-8535-11
Not in Commercial Distribution

  • 00822409029556 ()

  • Length: 35 Millimeter
  • Outer Diameter: 8.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
Diameter 7.5 mm x 35 mm Monoaxial Screw
Ortho Development Corporation
752-7535-31
Not in Commercial Distribution

  • 00822409029143 ()

  • Length: 35 Millimeter
  • Outer Diameter: 7.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
Diameter 7.5 mm x 35 mm Polyaxial Screw
Ortho Development Corporation
752-7535-11
Not in Commercial Distribution

  • 00822409029105 ()

  • Length: 35 Millimeter
  • Outer Diameter: 7.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
Diameter 6.5 mm x 35 mm Monoaxial Screw
Ortho Development Corporation
752-6535-31
Not in Commercial Distribution

  • 00822409028696 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 35 Millimeter


  • Spinal bone screw, non-bioabsorbable
Diameter 6.5 mm x 35 mm Polyaxial Screw
Ortho Development Corporation
752-6535-11
Not in Commercial Distribution

  • 00822409028658 ()

  • Length: 35 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
Diameter 5.5 mm x 35 mm Monoaxial Screw
Ortho Development Corporation
752-5535-31
Not in Commercial Distribution

  • 00822409028337 ()

  • Length: 35 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
Diameter 5.5 mm x 35 mm Polyaxial Screw
Ortho Development Corporation
752-5535-11
Not in Commercial Distribution

  • 00822409028290 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 35 Millimeter


  • Spinal bone screw, non-bioabsorbable
Diameter 4.5 mm x 35 mm Monoaxial Screw
Ortho Development Corporation
752-4535-31
Not in Commercial Distribution

  • 00822409027972 ()

  • Length: 35 Millimeter
  • Outer Diameter: 4.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
Diameter 4.5 mm x 35 mm Polyaxial Screw
Ortho Development Corporation
752-4535-11
Not in Commercial Distribution

  • 00822409027934 ()

  • Length: 35 Millimeter
  • Outer Diameter: 4.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
Diameter 8.5 mm x 35 mm Monoaxial Screw
Ortho Development Corporation
752-8535-31A
In Commercial Distribution

  • 00822409022823 ()

  • Length: 35 Millimeter
  • Outer Diameter: 8.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
Diameter 8.5 mm x 35 mm Polyaxial Screw
Ortho Development Corporation
752-8535-11A
In Commercial Distribution

  • 00822409022793 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 35 Millimeter


  • Spinal bone screw, non-bioabsorbable
Diameter 7.5 mm x 35 mm Monoaxial Screw
Ortho Development Corporation
752-7535-31A
In Commercial Distribution

  • 00822409022441 ()

  • Length: 35 Millimeter
  • Outer Diameter: 7.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
Diameter 7.5 mm x 35 mm Polyaxial Screw
Ortho Development Corporation
752-7535-11A
In Commercial Distribution

  • 00822409022410 ()

  • Length: 35 Millimeter
  • Outer Diameter: 7.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
Diameter 6.5 mm x 35 mm Monoaxial Screw
Ortho Development Corporation
752-6535-31A
In Commercial Distribution

  • 00822409022069 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 35 Millimeter


  • Spinal bone screw, non-bioabsorbable
Diameter 6.5 mm x 35 mm Polyaxial Screw
Ortho Development Corporation
752-6535-11A
In Commercial Distribution

  • 00822409022038 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 35 Millimeter


  • Spinal bone screw, non-bioabsorbable
Diameter 5.5 mm x 35 mm Monoaxial Screw
Ortho Development Corporation
752-5535-31A
In Commercial Distribution

  • 00822409021765 ()

  • Length: 35 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
Diameter 5.5 mm x 35 mm Polyaxial Screw
Ortho Development Corporation
752-5535-11A
In Commercial Distribution

  • 00822409021734 ()

  • Length: 35 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
Diameter 4.5 mm x 35 mm Monoaxial Screw
Ortho Development Corporation
752-4535-31A
In Commercial Distribution

  • 00822409021468 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 35 Millimeter


  • Spinal bone screw, non-bioabsorbable
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