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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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Imager Adaptor for SeaSpine® Lattus Retractor - 00850007069612

Imager Adaptor for SeaSpine® Lattus Retractor, 5-pk Carton
VISEON, INC.
LTS-S
In Commercial Distribution

  • 00850007069582 ()
  • 00850007069612 ()


  • General-purpose surgical microscope

SeaSpine - 00851797006429

Disposable Dilator Kit Kit Contains: ML-0444S Insulated Dilator Set, 7, 12, & 15 MM, Sterile ML-0445 Stimulation Clip, 5-22mm, Single Use, 1/Each, Sterile
TEDAN SURGICAL INNOVATIONS, L.L.C.
ML-0459
In Commercial Distribution

  • 00851797006429 ()

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


  • Analytical non-scalp cutaneous lead

Seaspine Orthopedics - B504OM8607120

No Description
Provision
86-0712
In Commercial Distribution

  • B504OM8607120 ()


  • Drilling power tool attachment, basic

SeaSpine Bi-Ostetic Cancellous Block, 40x6x6mm - 00858418003966

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

SeaSpine OLYMPUS Cable Adapter - 00812432022891

No Description
LUMITEX, INC.
007979
In Commercial Distribution

  • 00812432022891 ()
91-8412

  • Fibreoptic light cable

SeaSpine ACMI Cable Adapter - 00812432022884

No Description
LUMITEX, INC.
007978
In Commercial Distribution

  • 00812432022884 ()
91-8411

  • Fibreoptic light cable

SeaSpine WOLF Cable Adapter - 00812432022877

No Description
LUMITEX, INC.
007977
In Commercial Distribution

  • 00812432022877 ()
91-8410

  • Fibreoptic light cable

SeaSpine STORZ Cable Adapter - 00812432022860

No Description
LUMITEX, INC.
007976
In Commercial Distribution

  • 00812432022860 ()
91-8409

  • Fibreoptic light cable

Seaspine Orthopedics Retractor Illuminator - 00812432021412

No Description
LUMITEX, INC.
009133
In Commercial Distribution

  • 00812432021412 ()
91-8480

  • Surgical instrument fibreoptic light

SeaSpine Surgical Illuminator Cable - 00812432020675

No Description
LUMITEX, INC.
008329
In Commercial Distribution

  • 00812432020675 ()
91-8408

  • Fibreoptic light cable
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