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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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

  • 01812125010005 ()
KT03U01-1

  • Microplate IVD
  • Assay adhesive sealing/fixation film IVD
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
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
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
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
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
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
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
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
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)
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
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
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 102
Beckman Coulter, Inc.
C89644
In Commercial Distribution

  • 05099590753842 ()
  • 15099590765378 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Urine Combo 101
Beckman Coulter, Inc.
C89643
In Commercial Distribution

  • 05099590753835 ()
  • 15099590765361 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Urine Combo 87
Beckman Coulter, Inc.
B1017-437
Not in Commercial Distribution

  • 15099590704100 ()
  • 05099590704103 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Urine Combo 85
Beckman Coulter, Inc.
B1017-435
In Commercial Distribution

  • 15099590704087 ()
  • 05099590704080 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Urine Combo 103
Beckman Coulter, Inc.
C89645
In Commercial Distribution

  • 05099590753859 ()
  • 15099590765385 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Urine Combo 90
Beckman Coulter, Inc.
C48640
In Commercial Distribution

  • 15099590733919 ()
  • 05099590731239 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Urine Combo 89
Beckman Coulter, Inc.
C48639
In Commercial Distribution

  • 15099590733902 ()
  • 05099590731222 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Urine Combo 88
Beckman Coulter, Inc.
B1017-438
Not in Commercial Distribution

  • 15099590704117 ()
  • 05099590704110 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Urine Combo 86
Beckman Coulter, Inc.
B1017-436
In Commercial Distribution

  • 15099590704094 ()
  • 05099590704097 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Urine Combo 84
Beckman Coulter, Inc.
B1017-434
In Commercial Distribution

  • 15099590704070 ()
  • 05099590704073 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Pos Combo 46
Beckman Coulter, Inc.
B1017-220
In Commercial Distribution

  • 15099590704032 ()
  • 05099590704035 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Pos Combo 45
Beckman Coulter, Inc.
B1017-219
In Commercial Distribution

  • 15099590704025 ()
  • 05099590704028 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Assay Control is used to monitor extraction efficiency and PCR inhibition in the Acuitas AMR Gene Panel assay. A 2 mL screwcap tube containing approximately 90,000 CFU of Bacillus subtilis (ATCC 31028) dried down from a solution.
Opgen, Inc.
CP3233
Not in Commercial Distribution

  • 10812125010041 ()
CP3233

  • PCR/NAT negative control IVD
Identify Diagnostics Drug Test Cups CLIA WAIVED For In Vitro Diagnostics Use Only 12 Panel Configuration AMP1000, BAR300, BUP10, BZO300, COC300, MDMA500, MET1000, MOP300, MTD300, PCP25, OXY100, THC50 Contents: Test Cups - 2, PI - 1, Security Seals - 2
MEDICAL DISTRIBUTION GROUP INC
ID-CP12-BUP-AZ2
In Commercial Distribution

  • 00850013035212 ()
  • 10850013035219 ()
  • 20850013035216 ()
ID-CP12-BUP-AZ2

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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