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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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Complete Circle Health - 00860383000307

Home Midstream Pregnancy Test
PWL SOLUTIONS LLC
LMBCS20A99
Not in Commercial Distribution

  • 00860383000307 ()
  • 00860383000314 ()

  • Width: 6.0 Millimeter


  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid

IMMCO DIAGNOSTIC - 00845714004186

Counterstain
IMMCO DIAGNOSTICS, INC.
2510
In Commercial Distribution

  • 00845714004186 ()

  • 1 ml
2510

  • Evans blue solution IVD

OsteoMed - 00845694073684

ExtremiLock Ankle 1.6mm x 150mm K-Wire Sterile Qty 2
OSTEOMED LLC
321-0123-SP-02
In Commercial Distribution

  • 00845694073684 ()

  • Outer Diameter: 1.6 Millimeter
321-0123-SP-02

  • Orthopaedic bone screw, non-bioabsorbable, sterile

OsteoMed - 00845694082549

ExtremiLock Ankle 14 Hole 1/3 Tubular Plate Sterile Qty 2
OSTEOMED LLC
336-0014-SP-02
In Commercial Distribution

  • 00845694082549 ()

  • Length: 140 Millimeter
336-0014-SP-02

  • Orthopaedic bone screw, non-bioabsorbable, sterile

Femoral Cut Block, Central Capture, Klassic ONE - 00819251029605

Femoral Cut Block, Central Capture, Size 1
TOTAL JOINT ORTHOPEDICS, INC.
2141.01.000
In Commercial Distribution

  • 00819251029605 ()

  • Size 1


  • Orthopaedic implant aiming/guiding block, reusable

CUSTOMED - M20890027810

DISPOSABLE MUCUS TRAP, 80 ML (CC)
CUSTOMED INC
712057052781
In Commercial Distribution

  • M20890027812 ()
  • M20890027810 ()

  • Total Volume: 80 Milliliter
9002781

  • Sputum specimen container IVD

CUSTOMED - M20890027800

DISPOSABLE MUCUS TRAP, 40 ML (CC)
CUSTOMED INC
712057052780
In Commercial Distribution

  • M20890027800 ()
  • M20890027802 ()

  • Total Volume: 40 Milliliter
9002780

  • Sputum specimen container IVD

LipidPlus® Meter - 10763924550507

Lipid and Glucose Measuring System
JANT PHARMACAL CORPORATION
MD550
In Commercial Distribution

  • 10763924550507 ()


  • Glycated haemoglobin (HbA1c) monitoring system IVD, home-use
  • Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care
  • Home-use/point-of-care blood glucose/ketone monitoring system IVD

Gazelle PathoCatch - 08908016644022

COVID-19 Antigen Fluorescence Immunoassay Kit
MYLAB DISCOVERY SOLUTIONS PRIVATE LIMITED
MGPF25
In Commercial Distribution

  • 08908016644022 ()
MGPF25

  • SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid

PathoCatch - 08908016644015

COVID-19 Antigen Fluorescence Immunoassay Kit
MYLAB DISCOVERY SOLUTIONS PRIVATE LIMITED
MPF25
In Commercial Distribution

  • 08908016644015 ()
MPF25

  • SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid
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