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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PCR Plate Seal Package component of KT03U01-1 Acuitas AMR Gene Panel PCR Assay Plate Kit consisting of two (2) PCR Plate Seals pouched in a labeled clear plastic bag.
Opgen, Inc.
CP3445
Not in Commercial Distribution

  • 10812125010027 ()
CP3445

  • Assay adhesive sealing/fixation film IVD
12 Panel CLIA Waived Cup w/ 3 AD - Identify Health AMP500, BAR300, BUP10, BZO300, COC150, MTD300, MDMA500, MET500, OPI300, OXY100, TCA1000, THC50 (SG,OX,pH) 3mm Strip - 25 Pack
MEDICAL DISTRIBUTION GROUP INC
ID-H12-2-ADULT
In Commercial Distribution

  • 00850721007990 ()
  • 10850721007997 ()
ID-H12-2-ADULT

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The Programming Cassette is an accessory to the Accula Dock and facilitates reprogramming of the Dock’s embedded firmware. When firmware updates are needed, the firmware will be stored onto Programming Cassettes and sent to end users, who will load the Programming Cassette into their Dock and re-program its firmware
MESA BIOTECH, INC.
D2001
In Commercial Distribution

  • B540D20010 ()
D2001

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
The Accula Dock is an electronic module which executes in vitro diagnostic tests on compatible Test Cassettes. It consists of an electro-mechanical interface to a single Test Cassette. The Dock contains all electrical systems, controls and logic necessary to orchestrate in-vitro diagnostic tests within the inserted Test Cassette.
MESA BIOTECH, INC.
D2000
In Commercial Distribution

  • B540D20000 ()
D2000

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
No Description
Microgenics Corporation
10027480-U
In Commercial Distribution

  • 00884883007376 ()


  • Multiple-type sexually transmitted pathogen nucleic acid IVD, control
No Description
MONOBIND, INC.
8425-300
In Commercial Distribution

  • 00816870020433 ()

  • Width: 12 Inch
8425-300D

  • Alpha-fetoprotein (AFP) IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
7875-300
In Commercial Distribution

  • 00816870020280 ()

  • Width: 7.75 Inch
7875-300A

  • Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay
No Description
MONOBIND, INC.
8425-300
In Commercial Distribution

  • 00816870020440 ()

  • Width: 12 Inch
8425-300E

  • Alpha-fetoprotein (AFP) IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
7875-300
In Commercial Distribution

  • 00816870020297 ()

  • Width: 7.75 Inch
7875-300B

  • Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay
No Description
MONOBIND, INC.
8475-300
In Commercial Distribution

  • 00816870022116 ()

  • Width: 12 Inch
8475-300D

  • Alpha-fetoprotein (AFP) IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
7825-300
In Commercial Distribution

  • 00816870021966 ()

  • Width: 7.75 Inch
7825-300A

  • Folate (vitamin B9) IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
8025-300
In Commercial Distribution

  • 00816870021898 ()

  • Width: 7.75 Inch
8025-300D

  • Total triiodothyronine (TT3) IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
8475-300
In Commercial Distribution

  • 00816870022123 ()

  • Width: 12 Inch
8475-300E

  • Alpha-fetoprotein (AFP) IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
8475-300
In Commercial Distribution

  • 00816870022109 ()

  • Width: 7.75 Inch
8475-300B

  • Alpha-fetoprotein (AFP) IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
8025-300
In Commercial Distribution

  • 00816870021881 ()

  • Width: 7.75 Inch
8025-300B

  • Total triiodothyronine (TT3) IVD, kit, enzyme immunoassay (EIA)
No Description
GLOBAL SURGICAL CORPORATION
M 547FS22
In Commercial Distribution

  • 00810040251016 ()


  • General-purpose surgical microscope
"Keypoint Focus Workstation, DAN Including: - USFF PC with Keypoint software, 22” display - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - Cart with isolating power supply - System kit"
Alpine Biomed ApS
9033A072143
Not in Commercial Distribution

  • 05704736017794 ()


  • Electromyograph
"Keypoint Focus Workstation, ITA Including: - USFF PC with Keypoint software, 22” display - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - Cart with isolating power supply - System kit"
Alpine Biomed ApS
9033A072106
Not in Commercial Distribution

  • 05704736017282 ()


  • Electromyograph
"Keypoint Focus Workstation, NLD Including: - USFF PC with Keypoint software, 22” display - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - Cart with isolating power supply - System kit"
Alpine Biomed ApS
9033A072105
Not in Commercial Distribution

  • 05704736017275 ()


  • Electromyograph
"Keypoint Focus Workstation, SPA Including: - USFF PC with Keypoint software, 22” display - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - Cart with isolating power supply - System kit"
Alpine Biomed ApS
9033A072104
Not in Commercial Distribution

  • 05704736017268 ()


  • Electromyograph
"Keypoint Focus Workstation, DEU Including: - USFF PC with Keypoint software, 22” display - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - Cart with isolating power supply - System kit"
Alpine Biomed ApS
9033A072103
Not in Commercial Distribution

  • 05704736017251 ()


  • Electromyograph
"Keypoint Focus Workstation, ENG Including: - USFF PC with Keypoint software, 22” display - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - Cart with isolating power supply - System kit"
Alpine Biomed ApS
9033A0721BV
Not in Commercial Distribution

  • 05704736017206 ()


  • Electromyograph
ProMax Surgical Gown, MLR Front Yoke, Comfort Panel Back with Negastat, Snap Closures at Neck, Tape Tie Closures at Waist, With QCM, Circumferentially Offset Sleeves, Double-needle Flat Felled Chainstitch Construction
STANDARD TEXTILE CO., INC.
75614905
In Commercial Distribution

  • 00634916795493 ()


  • Surgical gown, reusable
Promax Backless Pathology Gown, 1-Ply Front Aqua ProMax, 2-Ply Aqua ProMax Sleeves, 1-Ply Aqua MLR Panel with Negastat Backs, Color Coded Tie Closures at Neck & Waist, Poly Cuffs, Size X-Large
STANDARD TEXTILE CO., INC.
75674164
In Commercial Distribution

  • 00634916684926 ()
  • 10634916684923 ()
75674164

  • Surgical gown, reusable
Promax Backless Pathology Gown, 1-Ply Front Aqua ProMax, 2-Ply Aqua ProMax Sleeves, 1-Ply Aqua MLR Panel with Negastat Backs, Color Coded Tie Closures at Neck & Waist, Poly Cuffs, Size Medium
STANDARD TEXTILE CO., INC.
75674166
Not in Commercial Distribution

  • 00634916684919 ()
  • 10634916684916 ()
75674166

  • Surgical gown, reusable
Promax Backless Pathology Gown, 1-Ply Front Aqua ProMax, 2-Ply Aqua ProMax Sleeves, 1-Ply Aqua MLR Panel with Negastat Backs, Color Coded Tie Closures at Neck & Waist, Poly Cuffs, Size Small
STANDARD TEXTILE CO., INC.
75674167
Not in Commercial Distribution

  • 00634916684896 ()
  • 10634916684893 ()
75674167

  • Surgical gown, reusable
A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Opiates, Methamphetamine, Cocaine, Phencyclidine, Amphetamine, Benzodiazepines, Methadone, Barbiturates, and Oxycodone drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
605204
In Commercial Distribution

  • 00690286000520 ()
  • 10690286000527 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, Phencyclidine, Methamphetamine (MAMP), 3,4-Methylenedioxymethamphetamine (MDMA) and Oxycodone drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601673
In Commercial Distribution

  • 00690286000308 ()
  • 10690286000305 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Methamphetamine (MAMP), Opiates, Amphetamine, Benzodiazepines, Methadone, Barbiturates, and Oxycodone drugs and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
604028
In Commercial Distribution

  • 10690286000053 ()
  • 00690286000056 ()


  • Multiplex analyser IVD, laboratory
  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The HarmonyAIR Hybrid High Definition Single Light, with Dual Flat Panel Monitor, No Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995176075 ()
LEH56NCND

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
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