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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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LIF AMP - 00190376422817

LIF AMP, TWO SCREW PLATE, 12 WITH CENTER SCREW, 10MM, AND CENTER SCREW - BACK TABLE
ALPHATEC SPINE, INC.
116-2-12-12-S
In Commercial Distribution

  • 00190376422817 ()


  • Spinal bone screw, non-bioabsorbable
  • Spinal fixation plate, non-bioabsorbable

LIF AMP - 00190376422794

LIF AMP, TWO SCREW PLATE, 10 WITH CENTER SCREW, 10MM, AND CENTER SCREW - BACK TABLE
ALPHATEC SPINE, INC.
116-2-12-10-S
In Commercial Distribution

  • 00190376422794 ()


  • Spinal bone screw, non-bioabsorbable
  • Spinal fixation plate, non-bioabsorbable

LIF AMP - 00190376422770

LIF AMP, TWO SCREW PLATE, 08 WITH CENTER SCREW, 10MM, AND CENTER SCREW - BACK TABLE
ALPHATEC SPINE, INC.
116-2-12-08-S
In Commercial Distribution

  • 00190376422770 ()


  • Spinal fixation plate, non-bioabsorbable
  • Spinal bone screw, non-bioabsorbable

LIF AMP - 00190376422756

LIF AMP, TWO SCREW PLATE, 06 WITH CENTER SCREW, 10MM, AND CENTER SCREW - BACK TABLE
ALPHATEC SPINE, INC.
116-2-12-06-S
In Commercial Distribution

  • 00190376422756 ()


  • Spinal fixation plate, non-bioabsorbable
  • Spinal bone screw, non-bioabsorbable

LIF AMP - 00190376422732

LIF AMP, TWO SCREW PLATE, 04 WITH CENTER SCREW, 10MM, AND CENTER SCREW - BACK TABLE
ALPHATEC SPINE, INC.
116-2-12-04-S
In Commercial Distribution

  • 00190376422732 ()


  • Spinal bone screw, non-bioabsorbable
  • Spinal fixation plate, non-bioabsorbable

ORLocate - 10724995221659

ORLocate Locator Drape with two straps, non-sterile is used with the ORLocate Sponge Solution System.
STERIS CORPORATION
ORLocate Drape
In Commercial Distribution

  • 50724995221657 ()
  • 10724995221659 ()
  • 00724995221652 ()
  • 15060356150011 ()
LC16601NS

  • Radio-frequency identification reader

ORLocate - 10724995221635

ORLocate HoveRead Drape with two straps, non-sterile is used with the ORLocate Sponge Solution System.
STERIS CORPORATION
ORLocate Drape
In Commercial Distribution

  • 50724995221633 ()
  • 10724995221635 ()
  • 00724995221638 ()
  • 15060356150035 ()
HC12631NS

  • Radio-frequency identification reader

Gyrus ACMI - 00821925017733

ASSEMBLY SYSTEM-CONTAINS TWO IMPLANTS-SCHURING COLUMELLA IMPLANT SYSTEM, TRIM TO LENGTH, 3.8MM DIA HEAD HYDROXYLAPATITE/FLUOROPLASTIC
Gyrus ACMI, LLC
141006-ENT
In Commercial Distribution

  • 00821925017733 ()


  • Ossicular prosthesis, partial

ArrowPhix System - B487EXARR9025260

ArrowPhix Compression Screw System The System includes the implant, two guide wires, and one driver.
Exsomed Corporation
EXARR902526
Not in Commercial Distribution

  • B487EXARR9025260 ()

  • Length: 26 Millimeter
  • Outer Diameter: 2.5 Millimeter
EXARR902526

  • Orthopaedic implant driver
  • Orthopaedic guidewire, single-use
  • Orthopaedic bone screw, non-bioabsorbable, sterile

EXAFAST™ - 10386040005388

EXAFAST™ NDS Heavy (yellow) Two Packs (2 x 48mL cartridges, 6 x mixing tips)
Gc America Inc.
137207
In Commercial Distribution

  • 20386040005385 ()
  • 10386040005388 ()

  • Total Volume: 48 Milliliter
137207

  • Silicone dental impression material
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