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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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SuperNova Nitrile Powder-Free, X-Small, Revolutionary stretchy nitrile provides superior comfort and increased tactile sensitivity, Textured fingertips, Packaging contains at least 70% recycled material, More gloves per box reduces packaging
PURELIFE, LLC
1061201
In Commercial Distribution

  • D79010612013 ()
  • D79010612011 ()
  • D79010612010 ()
1061201

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Drum is a hearing instrument test box (HIT), with a high ambient noise attenuation level, capable of performing all the tests aimed at hearing aids analysis via air conduction.
INVENTIS SRL
DRUM
In Commercial Distribution

  • 08054187380730 ()
11239

  • Hearing aid tester, electrical
Kit includes: PC-ECG 1200W (UDI: 07290110252076) wireless Stress-Test Kit; Input cable with ten leads AHA type and Clip connectors; Waiste Belt for mounting the wireless transmitter at Patient's hip.
NORAV MEDICAL LTD.
1200W Kit
In Commercial Distribution

  • 07290110255107 ()
1200W2-K-00-U-C10-17

  • Electrocardiography telemetric monitoring system transmitter
Liquid Urine Control - Level 1/Level 2, 25 ml. Contains 3 vials Level 1 and 3 vials Level 2. 18 month open vial stability when stored at 2-8° C.
ALTA DIAGNOSTICS INC
323-17-12
In Commercial Distribution

  • 30858512007137 ()

  • Total Volume: 25 Milliliter
323-17-12

  • Multiple urine analyte IVD, control
Liquid Urine Control - Level 1/Level 2, 10 ml. Contains 3 vials Level 1 and 3 vials Level 2. 18 month open vial stability when stored at 2-8° C.
ALTA DIAGNOSTICS INC
323-16-12
In Commercial Distribution

  • 30858512007106 ()

  • Total Volume: 10 Milliliter
323-16-12

  • Multiple urine analyte IVD, control
The ARK™ AB-PINACA Assay is an immunoassay intended for the qualitative determination of AB-PINACA and their metabolites in human urine at a cutoff concentration of 5 ng/mL.
ARK DIAGNOSTICS INC
5055-0001-01
In Commercial Distribution

  • 00812101030356 ()
5055-0001-01

  • Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
The ARK™ AB-PINACA Assay is an immunoassay intended for the qualitative determination of AB-PINACA and their metabolites in human urine at a cutoff concentration of 5 ng/mL.
ARK DIAGNOSTICS INC
5055-0001-00
In Commercial Distribution

  • 00812101030349 ()
5055-0001-00

  • Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
The DRI™ Fentanyl II Assay (Thermo Fisher) is an immunoassay intended for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL.
ARK DIAGNOSTICS INC
10028871
In Commercial Distribution

  • 00812101030769 ()
10028871

  • Fentanyl IVD, kit, enzyme immunoassay (EIA)
Calcium CPC Reagent Set for the quantitative determination of calcium in serum on Hitachi analyzers. For in vitro diagnostic use only. Packaged at 7 x 100ml, 3 x 100ml
POINTE SCIENTIFIC, INC.
HC902-1000
In Commercial Distribution

  • 00811727012609 ()
HC902-1000

  • Calcium (Ca2+) IVD, reagent
Amylase EPS Reagent Set for the quantitative kinetic determination of a-amylase activity in human serum. For in vitro diagnostic use only. Packaged at 12 x 22ml, 6 x 10ml
POINTE SCIENTIFIC, INC.
HA965-324
In Commercial Distribution

  • 00811727012562 ()
HA965-324

  • Total amylase IVD, kit, spectrophotometry
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