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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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GAUZE,SPONGE,XRAY,4"X4",16PLY,NS,LF
MEDLINE INDUSTRIES, INC.
NON25430
In Commercial Distribution

  • 40080196752851 ()
  • 20080196752857 ()
  • 10080196752850 ()
NON25430

  • Non-woven gauze pad, non-sterile
T.E.N.S. Device ; Pain Relief Therapy Kit.
ENDURANCE THERAPEUTICS INC.
AWDD
In Commercial Distribution

  • 00628055644002 ()


  • Arthritis TENS system
This is Box 2 of 3 for the Spartan RX CYP2C19 Platform. It contains the Spartan RX Netbook (01003214) and the Spartan RX Printer (01003438).
Spartan Bioscience Inc
01004985
In Commercial Distribution

  • 00628055420071 ()
01004985

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
This is Box 1 of 3 of the Spartan RX CYP2C19 Platform. It contains the Spartan RX Analyzer (01004777) and the Spartan RX Barcode Scanner (01003359).
Spartan Bioscience Inc
01004985
In Commercial Distribution

  • 00628055420064 ()
01004985

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
The Spartan RX Sample Transport System supplied with the Spartan RX CYP2C19 System. It includes: Carrying bag (01003374), Cold block (01003372), and Insulated box (01003373).
Spartan Bioscience Inc
01003374, 01003372, and 01003373
In Commercial Distribution

  • 00628055420057 ()
01003374, 01003372, and 01003373

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Barcode Scanner supplied with the Spartan RX CYP2C19 System.
Spartan Bioscience Inc
01003359
In Commercial Distribution

  • 00628055420040 ()
01003359

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Printer supplied with the Spartan RX CYP2C19 System
Spartan Bioscience Inc
01003438
In Commercial Distribution

  • 00628055420033 ()
01003438

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Netbook supplied with the Spartan RX CYP2C19 System.
Spartan Bioscience Inc
01003214
In Commercial Distribution

  • 00628055420026 ()
01003214

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Spartan RX Analyzer
Spartan Bioscience Inc
01004777
In Commercial Distribution

  • 00628055420019 ()
01004777

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
HCG Control Set Level B, for In Vitro Diagnostic Use. HCG Control is an unassayed, stable, ready to use liquid, bi-level control for use with assays designed to quantitate HCG. It is intended for determining “Hook-Dose Effect” and the accuracy and precision of dilution protocols. Size: 4 x 2.5 ml
Medtest Dx, Inc.
HCG-CTLB
In Commercial Distribution

  • 00817439020857 ()
HCG-CTLB

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, control
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