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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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Dimension® TACR Calibrator - 00842768004872

Tacrolimus Calibrator, 2x5x2mL
Siemens Healthcare Diagnostics Inc.
10445012
Not in Commercial Distribution

  • 00842768004872 ()
DC107

  • Tacrolimus therapeutic drug monitoring IVD, calibrator

VITA ADIVA F-CEM White Opaque - EHARFAFCEMWO51

Dual-curing adhesive composite
Harvard Dental International GmbH
FAFCEMWO5
In Commercial Distribution

  • EHARFAFCEMWO51 ()


  • Dental composite resin

VITA ADIVA F-CEM Translucent - EHARFAFCEMT51

Dual-curing adhesive composite
Harvard Dental International GmbH
FAFCEMT5
In Commercial Distribution

  • EHARFAFCEMT51 ()


  • Dental composite resin

VITA ADIVA F-CEM A3 - EHARFAFCEMA351

Dual-curing adhesive composite
Harvard Dental International GmbH
FAFCEMA35
In Commercial Distribution

  • EHARFAFCEMA351 ()


  • Dental composite resin

VITA ADIVA F-CEM A2 Universal - EHARFAFCEMA251

Dual-curing adhesive composite
Harvard Dental International GmbH
FAFCEMA25
In Commercial Distribution

  • EHARFAFCEMA251 ()


  • Dental composite resin

Harvard ZirconCore A3 - EHAR70836001

Dual cure core build-up and post cementing composite
Harvard Dental International GmbH
7083600
In Commercial Distribution

  • EHAR70836001 ()


  • Dental composite resin

Harvard ZirconCore A3 - EHAR177241

Dual cure core build-up and post cementing composite
Harvard Dental International GmbH
17724
In Commercial Distribution

  • EHAR177241 ()


  • Dental composite resin

USA Elite System - 00821925002074

USA Elite System Continuous Flow Resectoscope Outer Sheath, Raised Tip 25.6 Fr, (8.5 mm) Color Coded Yellow
Gyrus ACMI, LLC
EOS-CFR-25
In Commercial Distribution

  • 00821925002074 ()


  • General-purpose endoscopic needle, reusable

Liofilchem MIC Test Strip (MTS) - 08055182870080

MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Ceftolozane/Tazobactam 0.016/4 – 256/4 μg/mL are specialized strips impregnated with a predefined concentration gradient of ceftolozane/tazobactam for susceptibility testing of Enterobacter cloacae, E. coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa.
LIOFILCHEM SRL
Ceftolozane/Tazobactam 0.016/4 – 256/4 µg/mL 10 strips
In Commercial Distribution

  • 18055182870087 ()
  • 08055182870080 ()
  • 08055182870066 ()
$92146-10

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit

Liofilchem MIC Test Strip (MTS) - 08055182870073

MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Ceftolozane/Tazobactam 0.016/4 – 256/4 μg/mL are specialized strips impregnated with a predefined concentration gradient of ceftolozane/tazobactam for susceptibility testing of Enterobacter cloacae, E. coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa
LIOFILCHEM SRL
Ceftolozane/Tazobactam 0.016/4 – 256/4 µg/mL 1 strip
In Commercial Distribution

  • 28055182870077 ()
  • 08055182870073 ()
  • 18055182870070 ()
$92146-1

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit
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