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Company Name Brand Name GMDN Term 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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Disposable Dilator Kit Kit Contains: ML-0444S Insulated Dilator Set, 7, 12, & 15 MM, Sterile ML-0345 Dilator Clip
TEDAN SURGICAL INNOVATIONS, L.L.C.
ML-0459
In Commercial Distribution

  • 00851797006429 ()

  • Width: 15 Millimeter
  • Width: 12 Millimeter
  • Width: 7 Millimeter


  • Nerve-locating system, line-powered
SeaSpine Bi-Ostetic Cancellous Blocks is a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tri-calcium phosphate. SeaSpine Bi-Ostetic Cancellous Blocks is safe and has excellent biocompatibility. After it is implanted, the implant resorbs and is later replaced by natural bone. SeaSpine Bi-Ostetic Cancellous Blocks is a natural choice for sparing patients the trauma of autograft harvesting. It also provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission. SeaSpine Bi-Ostetic Cancellous Blocks is an osteoconductive bone substitute shaped as blocks that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The blocks may be pressed into the void or into the surgical site by hand. The SeaSpine Bi-Ostetic Cancellous Blocks provide void filling material that acts as a temporary support medium. The blocks are not intended to provide structural support during the healing process. The implant is radio-opaque. SeaSpine Bi-Ostetic Cancellous Blocks is biocompatible and resorbs in the body as bone ingrowth occurs.
BERKELEY ADVANCED BIOMATERIALS, LLC
SBiO-XYZ400606P
In Commercial Distribution

  • 00858418003966 ()
SBiO-XYZ400606P

  • Bone matrix implant, synthetic, non-antimicrobial
30mm Implant Caddy
SEASPINE ORTHOPEDICS CORPORATION
98-2923
In Commercial Distribution

  • 10889981123864 ()

  • 30mm
98-2923

  • Instrument tray
26mm Implant Caddy
SEASPINE ORTHOPEDICS CORPORATION
98-2922
In Commercial Distribution

  • 10889981123857 ()

  • 26mm
98-2922

  • Instrument tray
22mm Implant Caddy
SEASPINE ORTHOPEDICS CORPORATION
98-2921
In Commercial Distribution

  • 10889981123840 ()

  • 22mm
98-2921

  • Instrument tray
Implant Tray
SEASPINE ORTHOPEDICS CORPORATION
98-2920
In Commercial Distribution

  • 10889981123833 ()
98-2920

  • Instrument tray
Instrument Tray
SEASPINE ORTHOPEDICS CORPORATION
98-2900
In Commercial Distribution

  • 10889981123826 ()
98-2900

  • Instrument tray
Guide Hex Rod
SEASPINE ORTHOPEDICS CORPORATION
98-2205
In Commercial Distribution

  • 10889981123819 ()
98-2205

  • Orthopaedic implant/trial-implant/sizer holder, reusable
Bone Funnel
SEASPINE ORTHOPEDICS CORPORATION
98-2202
In Commercial Distribution

  • 10889981123802 ()
98-2202

  • Bone graft funnel
Driver
SEASPINE ORTHOPEDICS CORPORATION
98-2201
In Commercial Distribution

  • 10889981123796 ()
98-2201

  • Surgical drill guide, reusable
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