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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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BethaLoc® - 04048844235987

broach
implantcast GmbH
87001055
In Commercial Distribution

  • 04048844235987 ()

  • 5


  • Orthopaedic broach

n/a - 04048844234744

MK 4in1 femoral cutting block
implantcast GmbH
42204250
In Commercial Distribution

  • 04048844234744 ()

  • 5


  • Orthopaedic prosthesis implantation positioning instrument, reusable

ACS® - 04048844220532

SC FB tibial reaming guide right
implantcast GmbH
42150465
In Commercial Distribution

  • 04048844220532 ()

  • 5


  • Orthopaedic reamer guide

ACS® - 04048844214951

FB tibial trial component right
implantcast GmbH
42150515
In Commercial Distribution

  • 04048844214951 ()

  • 5


  • Knee tibia prosthesis trial, reusable

ACS® - 04048844212179

FB tibial trial component left
implantcast GmbH
42150505
In Commercial Distribution

  • 04048844212179 ()

  • 5


  • Knee tibia prosthesis trial, reusable

ACS® - 04048844212063

SC FB tibial reaming guide left
implantcast GmbH
42150455
In Commercial Distribution

  • 04048844212063 ()

  • 5


  • Orthopaedic reamer guide

ACS® - 04048844137717

SC femoral trial component right
implantcast GmbH
42103615
In Commercial Distribution

  • 04048844137717 ()

  • 5


  • Knee femur prosthesis trial, reusable

ACS® - 04048844137649

SC femoral trial component left
implantcast GmbH
42103605
In Commercial Distribution

  • 04048844137649 ()

  • 5


  • Knee femur prosthesis trial, reusable

U2 Total Knee System - 04719872175339

U2 Knee case #5
UNITED ORTHOPEDIC CORP.
9303-8050
In Commercial Distribution

  • 04719872175339 ()

  • #5
9303-8050

  • Instrument tray, reusable

U2™ Knee - 04719872174752

PSA Femoral resection guide, #5
UNITED ORTHOPEDIC CORP.
9303-2735-RA
In Commercial Distribution

  • 04719872174752 ()

  • #5
9303-2735-RA

  • Osteotomy guide, reusable

U2™ Knee - 04719872174585

MIS femoral cutting guide, #5
UNITED ORTHOPEDIC CORP.
9303-2351-RA
In Commercial Distribution

  • 04719872174585 ()

  • #5
9303-2351-RA

  • Osteotomy guide, reusable

U2™ Knee - 04719872174578

MIS femoral cutting guide, #5
UNITED ORTHOPEDIC CORP.
9303-2350-RA
In Commercial Distribution

  • 04719872174578 ()

  • #5
9303-2350-RA

  • Osteotomy guide, reusable

U2™ Knee - 04719872174561

MIS femoral cutting guide , #5
UNITED ORTHOPEDIC CORP.
9303-2350
In Commercial Distribution

  • 04719872174561 ()

  • #5
9303-2350

  • Osteotomy guide, reusable

U2 Hip Stem - 04719872167037

U2 Broach, #5
UNITED ORTHOPEDIC CORP.
9104-6050-RB
In Commercial Distribution

  • 04719872167037 ()

  • #5
9104-6050-RB

  • Orthopaedic broach

U2 Hip Stem - 04719872167020

U2 Broach, #5
UNITED ORTHOPEDIC CORP.
9104-6050-RA
In Commercial Distribution

  • 04719872167020 ()

  • #5
9104-6050-RA

  • Orthopaedic broach

U2™ Hip - 04719872167013

U2 Broach, #5
UNITED ORTHOPEDIC CORP.
9104-6050
In Commercial Distribution

  • 04719872167013 ()

  • #5
9104-6050

  • Orthopaedic broach

U2™ Knee - 04719872158400

Tibial sizing template, #5
UNITED ORTHOPEDIC CORP.
9403-7305
In Commercial Distribution

  • 04719872158400 ()

  • #5
9403-7305

  • Surgical implant template, reusable

U2™ Knee - 04719872158318

Femoral sizing template, #5
UNITED ORTHOPEDIC CORP.
9303-7315-RT
In Commercial Distribution

  • 04719872158318 ()

  • #5
9303-7315-RT

  • Surgical implant template, reusable

U2™ Knee - 04719872158301

Femoral sizing template, #5
UNITED ORTHOPEDIC CORP.
9303-7315-RB
In Commercial Distribution

  • 04719872158301 ()

  • #5
9303-7315-RB

  • Surgical implant template, reusable

U2™ Knee - 04719872158295

Femoral sizing template, #5
UNITED ORTHOPEDIC CORP.
9303-7315-RA
In Commercial Distribution

  • 04719872158295 ()

  • #5
9303-7315-RA

  • Surgical implant template, reusable
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