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

  • 10889981080464 ()
91-2099

  • Orthopaedic implantation sleeve, reusable
Reduction THD Driver 5.5/6.75 mm
Seaspine Orthopedics Corporation
91-1130
In Commercial Distribution

  • 10889981080372 ()

  • 5.5/6.75 mm
91-1130

  • Surgical screwdriver, reusable
4mm Hex, Large Axial Driver
Seaspine Orthopedics Corporation
91-1124
In Commercial Distribution

  • 10889981080365 ()

  • 4mm
91-1124

  • Surgical screwdriver, reusable
3mm Hex, Large Axial Driver
Seaspine Orthopedics Corporation
91-1123
In Commercial Distribution

  • 10889981080358 ()

  • 3mm
91-1123

  • Surgical screwdriver, 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 Limiting Hex Driver
Seaspine Orthopedics Corporation
91-1112
In Commercial Distribution

  • 10889981080310 ()
91-1112

  • Surgical screwdriver, reusable
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
Seaspine Orthopedics Corporation
91-0511
In Commercial Distribution

  • 10889981079987 ()

  • 3mm
91-0511

  • Orthopaedic implant driver
4mm Hex Shaft, 465SS
Seaspine Orthopedics Corporation
91-0158
In Commercial Distribution

  • 10889981079871 ()

  • 4mm
91-0158

  • 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 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
THD Hex Driver 5.5/6.75mm SYN
Seaspine Orthopedics Corporation
91-0134
In Commercial Distribution

  • 10889981079758 ()

  • 5.5/6.75mm
91-0134

  • Surgical screwdriver, reusable
THD Hex Driver 8.0mm STD
Seaspine Orthopedics Corporation
91-0131
In Commercial Distribution

  • 10889981079727 ()

  • 8.0mm
91-0131

  • Surgical screwdriver, reusable
THD Hex Driver 5.5/6.75mm STD
Seaspine Orthopedics Corporation
91-0130
In Commercial Distribution

  • 10889981079710 ()

  • 5.5/6.75mm
91-0130

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

  • 10889981079642 ()

  • 8"
91-0118

  • Orthopaedic implant driver
Install / Remove Tool, 5.5 / 6.75
Seaspine Orthopedics Corporation
91-0117
In Commercial Distribution

  • 10889981079635 ()

  • 5.5"/6.75"
91-0117

  • Orthopaedic implant driver
Hex Screwdriver 4mm
Seaspine Orthopedics Corporation
91-0112
In Commercial Distribution

  • 10889981079581 ()

  • 4mm
91-0112

  • Surgical screwdriver, reusable
Hex Driver 3mm
Seaspine Orthopedics Corporation
91-0111
In Commercial Distribution

  • 10889981079574 ()

  • 3mm
91-0111

  • Surgical screwdriver, reusable
No Description
Biomet Orthopedics, LLC
245015
In Commercial Distribution

  • 00880304288805 ()
245015

  • Surgical screwdriver, reusable
Instrument, Unigrip Driver, Wrench Insert, Short
SOUTHERN IMPLANTS (PTY) LTD
I-WI-UG-S
In Commercial Distribution

  • 06009544015253 ()


  • Surgical screwdriver, reusable
Instrument, Unigrip Driver, Wrench Insert, Medium
SOUTHERN IMPLANTS (PTY) LTD
I-WI-UG-M
In Commercial Distribution

  • 06009544015246 ()


  • Surgical screwdriver, reusable
Instrument, Unigrip Driver, Wrench Insert, Long
SOUTHERN IMPLANTS (PTY) LTD
I-WI-UG-L
In Commercial Distribution

  • 06009544015239 ()


  • Surgical screwdriver, reusable
Instrument, 1.22mm Tapered Hex Driver, Wrench Insert, Short
SOUTHERN IMPLANTS (PTY) LTD
I-WIT-22S
In Commercial Distribution

  • 06009544015222 ()


  • Dental implant/prosthesis surgical procedure kit
Instrument, 1.22mm Tapered Hex Driver, Wrench Insert, Medium
SOUTHERN IMPLANTS (PTY) LTD
I-WIT-22M
In Commercial Distribution

  • 06009544015215 ()


  • Dental implant/prosthesis surgical procedure kit
Instrument, 1.22mm Tapered Hex Driver, Wrench Insert, Long
SOUTHERN IMPLANTS (PTY) LTD
I-WIT-22L
In Commercial Distribution

  • 06009544015208 ()


  • Dental implant/prosthesis surgical procedure kit
Instrument, Converter for Southern Square
SOUTHERN IMPLANTS (PTY) LTD
I-WI-SS
In Commercial Distribution

  • 06009544015192 ()


  • Surgical torque wrench adaptor
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