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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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INnate Instrument Kit - B487EXINN9136000

INnate Sterile Instrument Kit The kit contains two guide wires, one cannulated drill, and one cannulated driver.
Exsomed Corporation
EXINN913600
Not in Commercial Distribution

  • B487EXINN9136000 ()
EXINN913600

  • Orthopaedic implant driver
  • Orthopaedic guidewire, single-use
  • Cannulated surgical drill bit, single-use
  • Surgical depth gauge, single-use

InFrame Instrument Kit - B487EXINF9120000

InFrame sterile instrument kit. The kit contains two step guide wires, one cannulated drill, one depth gauge
Exsomed Corporation
EXINF912000
Not in Commercial Distribution

  • B487EXINF9120000 ()
EXINF912000

  • Surgical depth gauge, single-use
  • Orthopaedic guidewire, single-use
  • Orthopaedic implant driver

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

TRIGEN - 03596010001399

LONG HEXDRIVER BAR
Smith & Nephew, Inc.
71631165
In Commercial Distribution

  • 03596010001399 ()
71631165

  • Surgical screwdriver, single-use

Main-Mallet-Spinal Simplicity - B908350011000

Single-Use, Surgical Mallet, Slotted, 8" Small Contoured Handle, 16oz Head Weight, Spinal Simplicity, Sterile
Mainstream Medical Devices, LLC
316-35-911
In Commercial Distribution

  • B908350011000 ()

  • Weight: 1 Pound
  • Length: 8 Inch
35-0011-000

  • Surgical mallet

Main-Mallet - B90831635080

Single-Use, Mallet, 8" Slotted, Small Contoured Handle, 16oz Head Weight, Sterile
Mainstream Medical Devices, LLC
316-35-080
In Commercial Distribution

  • B90831635080 ()

  • Weight: 1 Pound
  • Length: 8 Inch
316-35-080

  • Surgical mallet

Main-Mallet - B90831625080

Single-Use, Mallet, 8" Small Contoured Handle, 16oz Head Weight, Sterile
Mainstream Medical Devices, LLC
316-25-080
In Commercial Distribution

  • B90831625080 ()

  • Weight: 1 Pound
  • Length: 8 Inch
316-25-080

  • Surgical mallet

Main-Mallet - B90831225080

Single-Use, Mallet, 8" Small Contoured Handle, 12oz Head Weight, Sterile
Mainstream Medical Devices, LLC
312-25-080
In Commercial Distribution

  • B90831225080 ()

  • Weight: .75 Pound
  • Length: 8 Inch
312-25-080

  • Surgical mallet

Main-Mallet - B90830825080

Single-Use, Mallet, 8" Small Contoured Handle, 8oz Head Weight, Sterile
Mainstream Medical Devices, LLC
308-25-080
In Commercial Distribution

  • B90830825080 ()

  • Length: 8 Inch
  • Weight: .5 Pound
308-25-080

  • Surgical mallet

Aequalis Reversed II - 03700434023817

Hexagonal Tip AO
TORNIER
DWD167
In Commercial Distribution

  • 03700434023817 ()

  • Hex 2.5mm
DWD167

  • Surgical screwdriver, single-use
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