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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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ARK™ Ethyl Glucuronide Control is intended for use in quality control of the ARK™ Ethyl Glucuronide Assay.
ARK DIAGNOSTICS INC
5036-0003-01
In Commercial Distribution

  • 00858724003506 ()
5036-0003-01

  • Ethyl glucuronide (EtG) IVD, control
ARK™ Ethyl Glucuronide Control is intended for use in quality control of the ARK™ Ethyl Glucuronide Assay.
ARK DIAGNOSTICS INC
5036-0003-00
In Commercial Distribution

  • 00858724003490 ()
5036-0003-00

  • Ethyl glucuronide (EtG) IVD, control
The ARK™ Gabapentin Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of gabapentin in human serum or plasma on automated clinical chemistry analyzers. Gabapentin concentrations can be used as an aid in management of patients treated with gabapentin.
ARK DIAGNOSTICS INC
5025-0001-01
Not in Commercial Distribution

  • 00858724003261 ()
5025-0001-01

  • Neurontin (gabapentin) IVD, reagent
The ARK Methotrexate Assay (non c-Pack format) is a homogeneous enzyme immunoassay intended for the quantitative determination of methotrexate in human serum or plasma on automated clinical chemistry analyzers.
ARK DIAGNOSTICS INC
5026-0001-01
In Commercial Distribution

  • 00858724003216 ()
5026-0001-01

  • Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
This Keyguide is made from clear polycarbonate material and precisely engineered to help guide the user’s touch to targeted icons on the screen and reduce accidental activations. A tactile Keyguide allows the Accent 1000 to be set up to accommodate a wide range of cognitive and motor skills for the visually impaired. Using the Keyguide with the 1000 requires the device frame that came with the 1000. This keyguide has rectangular/oval openings and tactile ques for the visually impaired.
PRENTKE ROMICH COMPANY
18711-84
In Commercial Distribution

  • 00858526006675 ()


  • Voice synthesizer/digitizer
Alpha-Stim Earclip Electrode (AID) RoHS compliant
Electromedical Products International, Inc.
Earclip Electrode (AID) [RoHS]
Not in Commercial Distribution

  • 00857869005178 ()


  • Transcutaneous electrical stimulation electrode, single-use
Alpha-Stim Earclip Electrode (M) RoHS compliant
Electromedical Products International, Inc.
Earclip Electrode (M) [RoHS]
Not in Commercial Distribution

  • 00857869005161 ()


  • Transcutaneous electrical stimulation electrode, single-use
Alpha-Stim Leadwire (ASM) RoHS compliant
Electromedical Products International, Inc.
Alpha-Stim Leadwire (ASM) [RoHS}
Not in Commercial Distribution

  • 00857869005154 ()


  • Transcutaneous electrical stimulation lead
Alpha-Stim Earclip Electrode (M)
Electromedical Products International, Inc.
Earclip Electrode (M)
In Commercial Distribution

  • 00857869005147 ()


  • Transcutaneous electrical stimulation electrode, single-use
Alpha-Stim Earclip Electrode (AID)
Electromedical Products International, Inc.
Earclip Electrode (AID)
In Commercial Distribution

  • 00857869005130 ()


  • Transcutaneous electrical stimulation electrode, single-use
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