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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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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

RINGLOC + INSTRUMENTATION - 05019279415328

No Description
Biomet Uk Ltd
31-400624
In Commercial Distribution

  • 05019279415328 ()

  • SIZE 24
31-400624

  • Orthopaedic implant impactor, reusable

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

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

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

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

RINGLOC(R) ACETABULAR IMPACTOR PLATE - 00880304371156

No Description
Biomet Orthopedics, LLC
423334
In Commercial Distribution

  • 00880304371156 ()

  • SIZE 24
423334

  • Orthopaedic implant impactor, reusable

Arcos® Modular Revision Hip System - 00880304474352

No Description
Biomet Orthopedics, LLC
11-302124
In Commercial Distribution

  • 00880304474352 ()

  • 24 MM
11-302124

  • Coated femoral stem prosthesis, modular

RING RETAINER - 00880304567863

No Description
Biomet Orthopedics, LLC
110005138
In Commercial Distribution

  • 00880304567863 ()

  • SIZE 24
110005138

  • Orthopaedic implant impactor, reusable
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