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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No Description
MONOBIND, INC.
8075-300
In Commercial Distribution

  • 00816870023335 ()

  • Width: 7.75 Inch
8075-300D

  • Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay
No Description
MONOBIND, INC.
8575-300
In Commercial Distribution

  • 00816870023281 ()

  • Width: 7.75 Inch
8575-300A

  • Trisomy 21-risk hormone IVD, kit, chemiluminescent immunoassay
2-Ply Front/Sleeves Aqua Compel MLR and White ComPel MLR with Negastat, 1-Ply Aqua MLR Comfort Panel Backs, Snap Closures at Neck, Tie Closures at Waist, Circumferentially Offset Sleeves, Overcast Safety Stitch Body
STANDARD TEXTILE CO., INC.
75647454
In Commercial Distribution

  • 00634916788358 ()


  • Surgical gown, reusable
ComPel Surgical Gown, 2-Ply Front Beryl Green ComPel I, 2-Ply Beryl Green ComPel I Sleeves, Comfort Panel Back Panels with Carbon, Color Coded ComPel Neck Binding, Twill Tie Closures at Neck, Size 2XL
STANDARD TEXTILE CO., INC.
75614203
In Commercial Distribution

  • 00634916691641 ()
  • 10634916691648 ()
75614203

  • Surgical gown, reusable
ComPel Surg Gown 2-Ply Front/Sleeves of Beryl Green ComPel, 1-Ply Comfort Panel Back with Negastat, Color Coded ComPel Neck Binding, Tie Closure at Neck, Circumferentially Offset Sleeves, Overcast Safety Stitch Body, Large
STANDARD TEXTILE CO., INC.
75612345
Not in Commercial Distribution

  • 00634916348491 ()
  • 10634916348498 ()
75612345

  • Surgical gown, reusable
A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Methamphetamine (MAMP), Opiates, Amphetamine, Benzodiazepines, Tricyclic Antidepressants, Methadone, Barbiturates, Oxycodone, and Buprenorphine drugs and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
604032
In Commercial Distribution

  • 10690286000763 ()
  • 00690286000766 ()


  • Multiplex analyser IVD, laboratory
  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamine, Cocaine, Phencyclidine, Barbiturates, Benzodiazepines, Oxycodone, Methamphetamine (MAMP), 3,4-Methylenedioxymethamphetamine (MDMA), and Propoxyphene drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601677
In Commercial Distribution

  • 00690286000360 ()
  • 10690286000367 ()


  • 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, Tricyclic Antidepressants, Barbiturates, Methadone, Benzodiazepines, Propoxyphene (PPX), Methamphetamine (MAMP), 3,4-Methylenedioxymethamphetamine (MDMA) drugs and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601636
In Commercial Distribution

  • 10690286000282 ()
  • 00690286000285 ()


  • 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, Tricyclic Antidepressants, Methadone, Barbiturates, Oxycodone, and Propoxyphene drugs and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
604018
In Commercial Distribution

  • 00690286000018 ()
  • 10690286000015 ()


  • Multiplex analyser IVD, laboratory
  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PCR Assay Plate Kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) PCR Assay Plates and one (1) PCR Plate Seal Package in a labeled, white, reverse tuck box.
Opgen, Inc.
KT03U01-1
Not in Commercial Distribution

  • 01812125010005 ()
KT03U01-1

  • Microplate IVD
  • Assay adhesive sealing/fixation film IVD
D2RS is a direct digital dynamic remote-controlled fluoroscopy and radiography system equipped with the latest generation of Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography. Not for mammography.
STEPHANIX
D2RS_9090_AT_PA_NV2
In Commercial Distribution

  • 03664049001069 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital
D2RS is a direct digital dynamic remote-controlled fluoroscopy and radiography system equipped with the latest generation of Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography. Not for mammography.
STEPHANIX
D2RS_9090_B1_NV2
In Commercial Distribution

  • 03664049001052 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital
D2RS is a direct digital dynamic remote-controlled fluoroscopy and radiography system equipped with the latest generation of Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography. Not for mammography.
STEPHANIX
D2RS_9090_AT_PA
In Commercial Distribution

  • 03664049001045 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital
D2RS is a direct digital dynamic remote-controlled fluoroscopy and radiography system equipped with the latest generation of Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography. Not for mammography.
STEPHANIX
D2RS_9090_B1_N
In Commercial Distribution

  • 03664049001038 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital
D2RS is a direct digital dynamic remote-controlled fluoroscopy and radiography system equipped with the latest generation of Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography. Not for mammography.
STEPHANIX
D2RS_AT_PA_NV2
In Commercial Distribution

  • 03664049000062 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital
D2RS is a direct digital dynamic remote-controlled fluoroscopy and radiography system equipped with the latest generation of Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography. Not for mammography.
STEPHANIX
D2RS_B1_NV2
In Commercial Distribution

  • 03664049000055 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital
D2RS is a direct digital dynamic remote-controlled fluoroscopy and radiography system equipped with the latest generation of Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography. Not for mammography.
STEPHANIX
D2RS_AT_PA
In Commercial Distribution

  • 03664049000048 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital
D2RS is a direct digital dynamic remote-controlled fluoroscopy and radiography system equipped with the latest generation of Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography. Not for mammography.
STEPHANIX
D2RS_B1_N
In Commercial Distribution

  • 03664049000031 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital
PCR Assay Plate Kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) PCR Assay Plates and one (1) PCR Plate Seal Package in a labeled, white, reverse tuck box.
Opgen, Inc.
KT03U01-1
Not in Commercial Distribution

  • 20812125010000 ()
KT03U01-1

  • Microplate IVD
  • Assay adhesive sealing/fixation film IVD
The PRC Look™ Tracking System is setting a new standard for eye gaze systems. Compatible with the Accent 1400, now you can access the full communication & computing power with just your eyes! The PRC Look™ Tracking System attaches quickly to the Accent 1400 device to give users full visual control of the device. Keys are "selected" by gazing for a specified period of time to generate speech.
PRENTKE ROMICH COMPANY
PRCL-2
In Commercial Distribution

  • 00858526006712 ()

  • Weight: .10 Pound


  • Voice synthesizer/digitizer
ProMax Surgical Gown, MLR Front Yoke with Kaumograph, Comfort Panel Back with Negastat, Color Coded Neck Binding, Snap Closures at Neck, Color Coded Tie Closures at Waist, With QCM, Circumferentially Offset Sleeves, Size 2XL
STANDARD TEXTILE CO., INC.
75615073
In Commercial Distribution

  • 10634916819042 ()
  • 00634916819045 ()


  • Surgical gown, reusable
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, Phencyclidine, Tricyclic Antidepressants, Barbiturates, Methadone, Benzodiazepines, Methamphetamine (MAMP), 3,4-Methylenedioxymethamphetamine (MDMA) and Oxycodone drugs and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601684
In Commercial Distribution

  • 00690286000780 ()
  • 10690286000787 ()


  • 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, Tricyclic Antidepressants, Methadone, Barbiturates, Oxycodone, Propoxyphene, and Buprenorphine drugs and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
604022
In Commercial Distribution

  • 00690286000049 ()
  • 10690286000046 ()


  • Multiplex analyser IVD, laboratory
  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The xTAG® Cystic Fibrosis Kit is a device used to simultaneously detect and identify a panel of mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in human blood specimens
Luminex Molecular Diagnostics, Inc
I006C0068
Not in Commercial Distribution

  • 00840487100455 ()
I006C0068

  • Cystic fibrosis IVD, kit, multiplex
Blue Diamond® Patient Restraint Strap, extra long, is traditional rubber patient restraint with 2 airplane style buckles. It has a large mid panel that is protected by a removable Blue Diamond gel pad.
David Scott Company
BD2620XL
In Commercial Distribution

  • 15060797552139 ()

  • Width: 5 Inch
  • Length: 132 Inch
  • Height: .375 Inch
BD2620XL

  • Operating table patient pressure distribution pad, reusable
Device is a holder for digital detectors(DR Panels). It is used to hold digital detectors in place during radiographic exam. It allows for multiple orientations of the DR panel and features wheels for mobility
Reina Imaging
[T][#]-[Z]
In Commercial Distribution

  • 00860001700121 ()
Digital Detector Holder

  • X-ray film cassette holder
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, Phencyclidine, Tricyclic Antidepressants, Barbiturates, Methadone, Benzodiazepines, Propoxyphene (PPX), Methamphetamine (MAMP), 3,4 Methylenedioxymethamphetamine (MDMA) drugs and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601672
In Commercial Distribution

  • 10690286000299 ()
  • 00690286000292 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The PRC Look™ Tracking System is setting a new standard for eye gaze systems. Compatible with the Accent 1400 and Accent 1000, now you can access the full communication & computing power with just your eyes! The PRC Look™ Tracking System attaches quickly to the Accent 1400 or Accent 1000 device to give users full visual control of the device. Keys are "selected" by gazing for a specified period of time to generate speech.
PRENTKE ROMICH COMPANY
PRCL-1.1
In Commercial Distribution

  • 00858526006736 ()

  • Weight: .10 Pound


  • Voice synthesizer/digitizer
The PRC Look™ Tracking System is setting a new standard for eye gaze systems. Compatible with the Accent 1400 and Accent 1000, now you can access the full communication & computing power with just your eyes! The PRC Look™ Tracking System attaches quickly to the Accent 1400 or Accent 1000 device to give users full visual control of the device. Keys are "selected" by gazing for a specified period of time to generate speech.
PRENTKE ROMICH COMPANY
PRCL-1
In Commercial Distribution

  • 00858526006699 ()

  • Weight: .10 Pound


  • Voice synthesizer/digitizer
Control Swabs intended for use only with the ID NOW Influenza A & B product.
Alere Scarborough, Inc.
425-080
Not in Commercial Distribution

  • 10811877010439 ()


  • Influenza A/B virus nucleic acid IVD, control
No Description
MONOBIND, INC.
7025-300
In Commercial Distribution

  • 00816870021874 ()

  • Width: 7.75 Inch
7025-300E

  • Free triiodothyronine (FT3) IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
7025-300
In Commercial Distribution

  • 00816870021867 ()

  • Width: 7.75 Inch
7025-300D

  • Free triiodothyronine (FT3) IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
7025-300
In Commercial Distribution

  • 00816870021850 ()

  • Width: 7.75 Inch
7025-300B

  • Free triiodothyronine (FT3) IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
7075-300
In Commercial Distribution

  • 00816870023311 ()

  • Width: 7.75 Inch
7075-300E

  • Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay
No Description
MONOBIND, INC.
7075-300
In Commercial Distribution

  • 00816870023298 ()

  • Width: 7.75 Inch
7075-300B

  • Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay
ComPel Surgical Gown, 2-Ply Front Beryl Green ComPel I, 2-Ply Beryl Green ComPel I Sleeves, Comfort Panel Back Panels with Carbon, Color Coded ComPel Neck Binding, Tape Tie Closures at Neck and Waist, QCM, Size Large
STANDARD TEXTILE CO., INC.
75614305
In Commercial Distribution

  • 00634916691658 ()
  • 10634916691655 ()
75614305

  • Surgical gown, reusable
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, Phencyclidine, Tricyclic Antidepressants, Barbiturates, Methadone, Benzodiazepines, Propoxyphene (PPX), Methamphetamine (MAMP), 3,4-Methylenedioxymethamphetamine (MDMA) and Oxycodone drugs and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601674
In Commercial Distribution

  • 00690286000315 ()
  • 10690286000312 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The xTAG® Cystic Fibrosis 60 Kit v2 is a device used to simultaneously detect and identify a panel of mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in human blood specimens.
Luminex Molecular Diagnostics, Inc
I024C0181
In Commercial Distribution

  • 00840487100479 ()
I024C0181

  • Cystic fibrosis IVD, kit, multiplex
The xTAG® Cystic Fibrosis 39 Kit v2 is a device used to simultaneously detect and identify a panel of mutations and variants in the Cystic Fibrosis transmembrane conductance regulator (CFTR) gene in human blood specimens.
Luminex Molecular Diagnostics, Inc
I027C0231
In Commercial Distribution

  • 00840487100141 ()
I027C0231

  • Cystic fibrosis IVD, kit, multiplex
Neg Urine Combo 103
Beckman Coulter, Inc.
C89645
In Commercial Distribution

  • 05099590753859 ()
  • 15099590765385 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
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