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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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Instrument, 1.22mm/1.27mm Universal Hex Driver, Wrench Insert, Short
SOUTHERN IMPLANTS (PTY) LTD
I-WI-22U-S
In Commercial Distribution

  • 06009544032540 ()


  • Surgical screwdriver, reusable
Instrument, 1.22mm/1.27mm Universal Hex Driver, Wrench Insert, Long
SOUTHERN IMPLANTS (PTY) LTD
I-WI-22U-L
In Commercial Distribution

  • 06009544032526 ()


  • Surgical screwdriver, reusable
Instrument, 1.22mm/1.27mm Universal Hex Driver, Medium
SOUTHERN IMPLANTS (PTY) LTD
I-HD-22U-M
In Commercial Distribution

  • 06009544032472 ()


  • Surgical screwdriver, reusable
Instrument, 1.27mm Hex Driver, Long Handle
SOUTHERN IMPLANTS (PTY) LTD
I-HD-27-LH
In Commercial Distribution

  • 06009544026969 ()


  • Surgical screwdriver, reusable
Instrument, Converter for Southern Fixture Mount Hex
SOUTHERN IMPLANTS (PTY) LTD
I-WI-SH
In Commercial Distribution

  • 06009544024705 ()


  • Surgical torque wrench adaptor
No Description
Biomet Orthopedics, LLC
31-108100
In Commercial Distribution

  • 00880304302532 ()
31-108100

  • Surgical screwdriver, reusable
No Description
Biomet Orthopedics, LLC
31-107036
In Commercial Distribution

  • 00880304301993 ()
31-107036

  • Surgical screwdriver, reusable
Driver. The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactured from PEEK-OPTIMA® LT1 (ASYM F2026), titanium (Ti-6AI-4V ELI per ASTM F136) and cobalt chromium (Co-28Cr-6Mo per ASTM F1537) materials, with radiopaque tantalum markers (ASTM F560). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft.
Seaspine Orthopedics Corporation
98-2201
In Commercial Distribution

  • 10889981049577 ()
98-2201

  • Surgical drill guide, reusable
Expansion Driver. The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactured from PEEK-OPTIMA® LT1 (ASYM F2026), titanium (Ti-6AI-4V ELI per ASTM F136) and cobalt chromium (Co-28Cr-6Mo per ASTM F1537) materials, with radiopaque tantalum markers (ASTM F560). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft.
Seaspine Orthopedics Corporation
98-2010
Not in Commercial Distribution

  • 10889981049423 ()

  • 10mm
98-2010

  • Orthopaedic inorganic implant inserter/extractor, reusable
Expansion Driver. The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactured from PEEK-OPTIMA® LT1 (ASYM F2026), titanium (Ti-6AI-4V ELI per ASTM F136) and cobalt chromium (Co-28Cr-6Mo per ASTM F1537) materials, with radiopaque tantalum markers (ASTM F560). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft.
Seaspine Orthopedics Corporation
98-2002
In Commercial Distribution

  • 10889981049416 ()
98-2002

  • Surgical drill guide, reusable
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