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 Type Device Class Implantable

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TSC Uni-Planar Screw 7.0 x 35mm
Seaspine, Inc.
70-7035
Not in Commercial Distribution

  • M5567070351 ()
  • 10381780006046 ()

  • 7.0 x 35mm
70-7035

  • Multiple Rickettsia species (typhus group) immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent
Trial Rod, 4.8x600mm
SEASPINE ORTHOPEDICS CORPORATION
91-2984
In Commercial Distribution

  • 10889981082062 ()

  • 4.8x600mm
91-2984

  • Spinal implant trial
Trial Rod, 4.8 x 250mm
SEASPINE ORTHOPEDICS CORPORATION
91-2983
In Commercial Distribution

  • 10889981082055 ()

  • 4.8 x 250mm
91-2983

  • Spinal implant trial
Trial Rod, 4.8 x 110mm
SEASPINE ORTHOPEDICS CORPORATION
91-2982
In Commercial Distribution

  • 10889981082048 ()

  • 4.8 x 110mm
91-2982

  • Spinal implant trial
Trial Rod, 4.8 x 60mm
SEASPINE ORTHOPEDICS CORPORATION
91-2981
In Commercial Distribution

  • 10889981082031 ()

  • 4.8 x 60mm
91-2981

  • Spinal implant trial
Malibu Tray Lid
SEASPINE ORTHOPEDICS CORPORATION
91-2614
In Commercial Distribution

  • 10889981143480 ()
91-2614

  • Instrument tray, reusable
Crossbar Caddy
SEASPINE ORTHOPEDICS CORPORATION
91-2613
In Commercial Distribution

  • 10889981143473 ()
91-2613

  • Instrument tray, reusable
Rod Caddy
SEASPINE ORTHOPEDICS CORPORATION
91-2612
In Commercial Distribution

  • 10889981143466 ()
91-2612

  • Instrument tray, reusable
Cap Caddy
SEASPINE ORTHOPEDICS CORPORATION
91-2611
In Commercial Distribution

  • 10889981143459 ()
91-2611

  • Instrument tray, reusable
5.5mm, 6.5mm, & 7.5mm Screw Caddy
SEASPINE ORTHOPEDICS CORPORATION
91-2610
In Commercial Distribution

  • 10889981143442 ()
91-2610

  • Instrument tray, reusable
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