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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 (Small)
Seaspine Orthopedics Corporation
91-2099
In Commercial Distribution

  • 10889981080464 ()
91-2099

  • Orthopaedic implantation sleeve, reusable
3mm Driver, Small T-Handle
Seaspine Orthopedics Corporation
91-1115
In Commercial Distribution

  • 10889981080341 ()

  • 3mm
91-1115

  • Surgical instrument handle, non-torque-limiting
CROSSBAR HEX DRIVER
Seaspine Orthopedics Corporation
91-1111
In Commercial Distribution

  • 10889981080303 ()
91-1111

  • Orthopaedic implant driver
RATCHETING DRIVER HANDLE
Seaspine Orthopedics Corporation
91-0917
In Commercial Distribution

  • 10889981080211 ()
91-0917

  • Surgical instrument handle, non-torque-limiting
4MM HEX SHAFT
Seaspine Orthopedics Corporation
91-0512
In Commercial Distribution

  • 10889981079994 ()

  • 4mm
91-0512

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

  • 10889981079864 ()

  • 3mm
91-0157

  • Orthopaedic implant driver
THD Driver Sleeve 8.0mm
Seaspine Orthopedics Corporation
91-0137
In Commercial Distribution

  • 10889981079789 ()

  • 8.0mm
91-0137

  • Orthopaedic implantation sleeve, reusable
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
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