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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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The VERIFY All-In-One Steam Reusable Test Pack is designed to challenge vacuum assisted steam sterilizers operating at 270°F for a 4-minute exposure and can be used 200 times.
STERIS CORPORATION
LCB055
In Commercial Distribution

  • 00724995162771 ()
LCB055

  • Chemical/physical sterilization process indicator
The Prep-Check 30Hz is a hand-held, battery powered device intended to measure the electrical impedance of bio-potential electrodes a applied to patients. Impedance readings are measured at 30 Hz.
General Devices
Prep-Check 30Hz
Not in Commercial Distribution

  • 00862186000317 ()
EIM-105-30Hz

  • Electrocardiographic electrode tester
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
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)
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)
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
Kit to assist with basic Body Fluids cleanup intended for use at general workplaces, typically accompanying first aid kits for spilled blood or other bodily fluids. Managed First Aid.
REDICARE LLC
Bodily Fluid Cleanup Kit
In Commercial Distribution

  • B70901020740 ()
0102074

  • First aid kit, medicated
Blue Titanium Round Handle Bayonet Bipolar Forcep 9" (228.60mm) Irrigating And Insulated With A Gold 10mm Area With A 0.25mm High Polished Anti-Stick Tip (*** PRODUCT MAY SCISSOR AT TIPS ***)
TITAN MANUFACTURING INC
283728449010101
In Commercial Distribution

  • 00817914024363 ()

  • Length: 9 Inch


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
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