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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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ELVIS REPLACEMENT MEDIUM
DIAGNOSTIC HYBRIDS, INC.
10-220500
In Commercial Distribution

  • 30014613331209 ()
10-220500

  • Cell culture medium IVD
ELVIS REPLACEMENT MEDIUM
DIAGNOSTIC HYBRIDS, INC.
10-220100
In Commercial Distribution

  • 30014613331193 ()
10-220100

  • Cell culture medium IVD
RC RMIX REFEED MEDIUM
DIAGNOSTIC HYBRIDS, INC.
05-370100
In Commercial Distribution

  • 30014613331018 ()
05-370100

  • Cell culture medium IVD
RC RMIX RINSE BUFFER
DIAGNOSTIC HYBRIDS, INC.
05-360075
In Commercial Distribution

  • 30014613331001 ()
05-360075

  • Cell culture medium IVD
No Description
ergoline GmbH
705780
In Commercial Distribution

  • 04059358001470 ()


  • Bicycle ergometer
VADER Pedicle System, VADER Pedicle System Navigated Instruments, Container, complete
icotec AG
42-700
In Commercial Distribution

  • 07640172552438 ()
42-700

  • Device sterilization/disinfection container, reusable
MRSA / VRE BIPLATE (Sect. 1: MH with 4% NaCl and Oxacillin 6mcg/ml; Sect II: BHI Agar with Vancomycin 6mcg/ml). For the detection of Methicillin Resistant Staphylococcus aureus and Vancomycin Resistant Enterococci.
HARDY DIAGNOSTICS
J112
Not in Commercial Distribution

  • 00816576020225 ()
  • 00816576021307 ()
J112

  • Multiple formulation agar culture medium IVD
Tidal Volume Range(250-1500mL), Media(Foam), Dead Space(38mL), Breathing Resistance(2.5cm H2O at 60L /min) Weight(9g)
Dynarex Corporation
30201
In Commercial Distribution

  • 00840117305427 ()
  • 00840117305410 ()


  • Heat/moisture exchanger/microbial medical gas filter
The Simplex instrument automates placement of up to 6 different Etest strips from foam packaging directly onto agar plates.
BIOMERIEUX SA
559802
In Commercial Distribution

  • 03573026250768 ()


  • Antimicrobial susceptibility strip dispenser IVD
University of Kansas colibri corneal forceps, 4 1/4'', 0.12mm 2x2 teeth set at 45 degrees with 7.0mm tying platforms, flat handle
AMBLER SURGICAL CORP.
University of Kansas colibri corneal forceps
In Commercial Distribution

  • 00190660076429 ()
2336E

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
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