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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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Alinity i BRAHMS PCT Controls
Abbott Ireland Diagnostics
01R1810
In Commercial Distribution

  • 00380740153946 ()
01R1810

  • Procalcitonin (PCT) IVD, control
The A1CNow+ Controls™ are supplied in two levels as a frozen, ready-to-use material that requires no reconstitution. The control consists of human whole blood modified to target levels with reagent chemicals to produce the desired reaction when tested by the A1CNow system. Stabilizers and preservatives have been added to maintain shelf life and inhibit microbial growth.
POLYMER TECHNOLOGY SYSTEMS, INC.
737
In Commercial Distribution

  • 00381930737014 ()
737

  • Glycated haemoglobin (HbA1c) IVD, control
ARCHITECT BNP Controls
Abbott GmbH
08K2813
In Commercial Distribution

  • 00380740190378 ()
08K2813

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control
No Description
Around Body Co., Ltd.
JIHE-PANTYLINER
In Commercial Distribution

  • 08809990301010 ()


  • Menstrual pad, unscented
No Description
PREVEST DENPRO LIMITED
1.3mm 10 upper and 10 lower
In Commercial Distribution

  • D967130010 ()
13001

  • Dental base plate
10 in Aqua Spectrum (Concentrated) (ASR)
CYTOCELL LIMITED
MPP36553
In Commercial Distribution



  • Assay development analyte-specific reagent IVD
MPP36553 10 in Aqua Spectrum (Concentrated)
CYTOCELL LIMITED
MPP36553
In Commercial Distribution

  • 05055844915763 ()


  • Assay development analyte-specific reagent IVD
KIT, EASYSAMPLER, NO SUBSTRATE, 10 SAMPLE
QUINTRON INSTRUMENT COMPANY, INC.
QT04208
In Commercial Distribution

  • 00850010197104 ()
QT04208

  • Breath specimen container IVD
Screw Driver w/ Thread, Size 10
K2M, INC.
SP-4212
In Commercial Distribution

  • 10888857488649 ()

  • Size 10 Hexalobe
SP-4212

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Integrated Graft Ramps, Size 10 mm
K2M, INC.
AG01-96093
In Commercial Distribution

  • 10888857469563 ()
AG01-96093

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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