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
Head Inserter
SEASPINE ORTHOPEDICS CORPORATION
90-0230
In Commercial Distribution

  • 10889981129262 ()
90-0230

  • Orthopaedic implant inserter/extractor, reusable
Malleable Rod, 400mm
SEASPINE ORTHOPEDICS CORPORATION
25-20-0400
In Commercial Distribution

  • 10889981114046 ()

  • 400mm
25-20-0400

  • Vertebral body prosthesis, non-sterile
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
Caddy Tray
SEASPINE ORTHOPEDICS CORPORATION
91-2609
In Commercial Distribution

  • 10889981143435 ()
91-2609

  • Instrument tray, reusable
Malibu Instrument Tray 2, Inner Tray 4
SEASPINE ORTHOPEDICS CORPORATION
91-2608
In Commercial Distribution

  • 10889981143428 ()
91-2608

  • Instrument tray, reusable
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