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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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INTROCAN SAFETY® - 04046963358679

Introcan Safety® IV Catheter 24 Ga. x 0.55 in., FEP, Straight, Thinwall
B. BRAUN MEDICAL INC.
4251612-02
Not in Commercial Distribution

  • 04046963358686 ()
  • 04046963358679 ()
  • 04046963326340 ()

  • Catheter-Gauge : 24
4251612-02

  • Peripheral vascular intervention infusion catheter

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

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

Vanguard® 360 Instrument - 00887868484780

No Description
Biomet Orthopedics, LLC
32-360894
In Commercial Distribution

  • 00887868484780 ()

  • 24 mm
32-360894

  • Medullary canal orthopaedic reamer, flexible

Arcos® Modular Revision System - 00887868477799

No Description
Biomet Orthopedics, LLC
31-301835
In Commercial Distribution

  • 00887868477799 ()

  • 24 mm
31-301835

  • Medullary canal orthopaedic reamer, flexible

Arcos® Modular Revision System - 00887868475351

No Description
Biomet Orthopedics, LLC
31-300574
In Commercial Distribution

  • 00887868475351 ()

  • Size 24
31-300574

  • Bone-resection orthopaedic reamer, reusable
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