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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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MOBIO™ Total Knee System - 00843575112934

Spacer Block, Size BC, 9/10mm
B-ONE ORTHO, CORP.
8829211002
In Commercial Distribution

  • 00843575112934 ()
8829211002

  • Orthopaedic implant/instrument assembling device

Kosmo Femoral Hip System - 00843575110466

Standard Collared Hip Stem Size 9
B-ONE ORTHO, CORP.
8810101070
In Commercial Distribution

  • 00843575110466 ()
8810101070

  • Press-fit femoral stem prosthesis

MOBIO™ Total Knee System - 00843575107015

CR Femoral Trial, Size 9, Right
B-ONE ORTHO, CORP.
8829111092
In Commercial Distribution

  • 00843575107015 ()
8829111092

  • Knee femur prosthesis trial, reusable

MOBIO™ Total Knee System - 00843575107008

CR Femoral Trial, Size 9, Left
B-ONE ORTHO, CORP.
8829111091
In Commercial Distribution

  • 00843575107008 ()
8829111091

  • Knee femur prosthesis trial, reusable

MOBIO™ Total Knee System - 00843575104359

Spacer Block Size DE 9/10mm
B-ONE ORTHO, CORP.
8829211004
In Commercial Distribution

  • 00843575104359 ()
8829211004

  • Orthopaedic implant/instrument assembling device

Spinal Needle - 04526737170282

22G x 9"(229mm) Metal hub
HAKKO CO.,LTD.
9-1149-22
In Commercial Distribution

  • 04526737170282 ()
  • 14526737170289 ()

  • Needle Gauge: 22 Gauge
  • Length: 229 Millimeter


  • Peripheral nerve-block sharp needle

Conformity stem, coxa vara, collared, #9 - 04711605583466

Conformity stem, coxa vara, collared, #9
UNITED ORTHOPEDIC CORP.
1110-5209
In Commercial Distribution

  • 04711605583466 ()
1110-5209

  • Metal-on-polyethylene total hip prosthesis
  • Revision coated hip femur prosthesis
  • Coated hip femur prosthesis, modular

Conformity stem, high offset, collared, #9 - 04711605583138

Conformity stem, high offset, collared, #9
UNITED ORTHOPEDIC CORP.
1110-1209
In Commercial Distribution

  • 04711605583138 ()
1110-1209

  • Metal-on-polyethylene total hip prosthesis
  • Revision coated hip femur prosthesis
  • Coated hip femur prosthesis, modular

United Hip System - 04711605583749

Conformity stem, cemented, high offset, #9
UNITED ORTHOPEDIC CORP.
1110-7209
In Commercial Distribution

  • 04711605583749 ()
1110-7001

  • Metal-on-polyethylene total hip prosthesis

SCANLAN® Thoracoscopic Reliance Bulldog Clamp Applier - 00846159029154

Reliance Bulldog Clamp Applier 9"/23cm
SCANLAN INTERNATIONAL INC
9009-393
In Commercial Distribution

  • 00846159029154 ()
9009-393

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
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