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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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Polyaxial Screw Driver, 8.0+
Seaspine Orthopedics Corporation
91-2109
In Commercial Distribution

  • 10889981080563 ()
91-2109

  • Surgical screwdriver, reusable
Modular Poly Driver Sleeve, 8.0+
Seaspine Orthopedics Corporation
91-2107
In Commercial Distribution

  • 10889981080549 ()
91-2107

  • Orthopaedic implantation sleeve, reusable
Malibu Driver Sleeve (Large)
Seaspine Orthopedics Corporation
91-2100
In Commercial Distribution

  • 10889981080471 ()
91-2100

  • Orthopaedic implantation sleeve, reusable
Malibu Driver Sleeve (Small)
Seaspine Orthopedics Corporation
91-2099
In Commercial Distribution

  • 10889981080464 ()
91-2099

  • Orthopaedic implantation sleeve, reusable
3mm Hex Shaft
Seaspine Orthopedics Corporation
91-0511
In Commercial Distribution

  • 10889981079987 ()

  • 3mm
91-0511

  • Orthopaedic implant driver
3mm Hex Shaft, 465SS
Seaspine Orthopedics Corporation
91-0157
In Commercial Distribution

  • 10889981079864 ()

  • 3mm
91-0157

  • Orthopaedic implant driver
UCR HEX TIP INSERTER SHAFT
Seaspine Orthopedics Corporation
91-0154
In Commercial Distribution

  • 10889981079833 ()
91-0154

  • Orthopaedic implant driver
THD Driver Sleeve 5.5 / 6.75mm
Seaspine Orthopedics Corporation
91-0136
In Commercial Distribution

  • 10889981079772 ()

  • 5.5 / 6.75mm
91-0136

  • Orthopaedic implantation sleeve, reusable
THD Hex Driver 8.0mm STD
Seaspine Orthopedics Corporation
91-0131
In Commercial Distribution

  • 10889981079727 ()

  • 8.0mm
91-0131

  • Surgical screwdriver, reusable
Install / Remove Tool, 8.0
Seaspine Orthopedics Corporation
91-0118
In Commercial Distribution

  • 10889981079642 ()

  • 8"
91-0118

  • Orthopaedic implant driver
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