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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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MEDALLION MODULAR HIP SYSTEM - 00880304640047

No Description
Biomet Orthopedics, LLC
71-007001
In Commercial Distribution

  • 00880304640047 ()

  • 24 MM
71-007001

  • Uncoated hip femur prosthesis, modular

Alexis Wound Protector-Retractor - 00607915117245

Wound Retractor and Protector
APPLIED MEDICAL RESOURCES CORPORATION
C8312
In Commercial Distribution

  • 10607915117242 ()
  • 00607915117245 ()

  • 2-4 cm


  • Radial surgical retractor

Alexis Wound Protector-Retractor - 00607915132958

Wound Retractor and Protector
APPLIED MEDICAL RESOURCES CORPORATION
C8322
In Commercial Distribution

  • 10607915132955 ()
  • 00607915132958 ()

  • 2-4 cm


  • Radial surgical retractor

IMMCO DIAGNOSTICS - 00845714001208

Anti-Neutrophil Cytoplasmic Antibody (ANCA) IFA Kit
IMMCO DIAGNOSTICS, INC.
1116X
In Commercial Distribution

  • 00845714001208 ()

  • 24 determinations
116X

  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay

IMMCO DIAGNOSTICS - 00845714000317

Anti-Neutrophil Cytoplasmic Antibody (ANCA) IFA Kit
IMMCO DIAGNOSTICS, INC.
1116
In Commercial Distribution

  • 00845714000317 ()

  • 24 determinations
1116

  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay

MONOFLUO - 00847865001519

MONOFLUO Pneumocystis jirovecii (P. carinii) IFA Test
Bio-RAD Laboratories, Inc.
32515
In Commercial Distribution

  • 00847865001519 ()

  • 24 Tests
32515

  • Pneumocystis jirovecii antigen IVD, kit, direct fluorescent test (DFT)

Kallestad - 00847865001496

MONOFLUO Legionella pneumophila IFA Test Kit
Bio-RAD Laboratories, Inc.
32514
In Commercial Distribution

  • 00847865001496 ()

  • 24 Tests
32514

  • Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

Ascend - 00846832024049

DISTAL SOUNDER
TORNIER, INC.
SH069704
In Commercial Distribution

  • 00846832024049 ()

  • Size 2-4
SH069704

  • Orthopaedic prosthesis implantation positioning instrument, reusable

ACRYSOF® IQ RESTOR® - 00380655101193

AcrySof(R) ReSTOR(R) APODIZED DIFFRACTIVEASPHERIC SINGLE-PIECE IOL, 13.0mm LENGTH,6.0mm OPTIC, PLANAR HAPTICS.
Alcon Laboratories, Inc.
SN6AD3
Not in Commercial Distribution

  • 00380655101193 ()

  • Diopter 24


  • Posterior-chamber intraocular lens, pseudophakic

AcrySof® ACRYSERT® - 00380655097540

AcrySof(R) IQ ASPHERIC Natural SP IOL WITHTHE AcrySert(R) DELIVERY SYSTEM, UV WITH BLUELIGHT FILTER, 13.0mm LENGTH, 6.0mm ANTERIORASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS.
Alcon Laboratories, Inc.
SN60WS
Not in Commercial Distribution

  • 00380655097540 ()

  • Diopter 24
SN60WS.240

  • Posterior-chamber intraocular lens, pseudophakic
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