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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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House Brand Dentistry - 00810132802324

HSB - Burnisher D/E #21B Acorn
Frontier Dental Supply Inc
HSB-300115
In Commercial Distribution

  • 00810132802324 ()


  • Manual dental burnisher, reusable

NA - 00199150021109

CUSTOM PACK BB6X07R3 2PK 38 E
MEDTRONIC, INC.
BB6X07R3
In Commercial Distribution

  • 20199150021110 ()
  • 00199150021109 ()


  • Cardiopulmonary bypass system blood tubing set

NA - 00199150021697

CUSTOM PACK BB1B37R38 E WO R
MEDTRONIC, INC.
BB1B37R38
In Commercial Distribution

  • 00199150021697 ()


  • Cardiopulmonary bypass system blood tubing set

Newport - 10884521541047

e360 Ventilator with Accessories;E Model
Covidien LP
E360P-SY-NA
Not in Commercial Distribution

  • 10884521541047 ()
E360P-SY-NA

  • Neonatal/adult intensive-care ventilator

T2Bacteria® QCheck Positive Kit - M70885080730

Positive ASK Control, Positive EPE Control
T2 BIOSYSTEMS, INC.
85-08073
In Commercial Distribution

  • M70885080730 ()

  • Total Volume: 4 Milliliter


  • Multiple bloodstream bacteria nucleic acid IVD, control

T2Bacteria® QCheck Negative Kit - M70885080743

Negative Control for T2Bacteria Panel
T2 BIOSYSTEMS, INC.
85-08074
In Commercial Distribution

  • M70885080743 ()
  • M70883080760 ()

  • Total Volume: 4 Milliliter


  • Multiple bloodstream bacteria nucleic acid IVD, control

T2Bacteria® QCheck Positive Kit - M70885071910

Positive SK Control, Positive EPE Control
T2 BIOSYSTEMS, INC.
85-07191
In Commercial Distribution

  • M70885071910 ()

  • Total Volume: 4 Milliliter


  • Multiple bloodstream bacteria nucleic acid IVD, control

VIVIT Supply - 10810141931401

Commend Nitrile Exam Glove, Chemo Drug Tested, Textured Fingertips, Powder-Free,
Vivit Supply LLC
20121
In Commercial Distribution

  • 20810141931408 ()
  • 10810141931401 ()
  • 00810141931404 ()


  • Total immunoglobulin E (IgE total) IVD, kit, rapid ICT, clinical

BD MAX™ Enteric Viral Panel - 00382904439859

Kit BD MAX Enteric Viral Panel
BECTON, DICKINSON AND COMPANY
443985
In Commercial Distribution

  • 00382904439859 ()
443985

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

BD MAX™ Enteric Parasite Panel - 00382904429607

Kit BD MAX Enteric Parasite Panel
BECTON, DICKINSON AND COMPANY
442960
In Commercial Distribution

  • 00382904429607 ()
442960

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
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