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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iScreen™ Urine Test Visual X Drug Screen Cup 10 Panel with Adulterants E&I (OX/pH/CR)(AMP500/BAR300/BZO300/THC50/COC150/MTD300/MET500/OPI2000/OXY100/PCP25)
Instant Technologies, Inc.
TDOA-XC10A
In Commercial Distribution

  • 00817405021383 ()
  • 10817405021380 ()
TDOA-XC10A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,PH) 12 Panel Drug Screen for (THC/COC/MOP/AMP/MET/BAR/BZO/PCP/MDMA/MTD/OXY/TCA)
Instant Technologies, Inc.
USSCupA-12CLIA
Not in Commercial Distribution

USSCUPA-12CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,PH) 12 Panel Drug Screen for (COC/MOP/AMP/MET/BAR/BZO/BUP/PCP/MDMA/MTD/OXY/TCA)
Instant Technologies, Inc.
USSCupA-12NTCLIA
In Commercial Distribution

USSCUPA12NTCLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,PH) 12 Panel Drug Screen for (THC/COC/MOP/AMP/MET/PCP/BZO/BAR/BUP/MDMA/MTD/OXY)
Instant Technologies, Inc.
USSCupA-12BUP300CLIA
In Commercial Distribution

USSCUPA-12BUP30

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 10 Panel Drug Screen for (AMP/BAR/BUP/BZO/COC/MET/OPI300/OXY/MTD/THC)
Instant Technologies, Inc.
I-DXP-2107-01
In Commercial Distribution

  • 00817405020355 ()
I-DXP-2107-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
(Identify USA - Drug Test Cups) / 12 Panel CLIA Waived Cup - AMP500, BAR300, BUP10, BZO300, COC150, MTD300, MDMA500, MET500, MOR/OPI300, OXY100, PCP25, THC50 3mm Strip - 25 Pack Box
MEDICAL DISTRIBUTION GROUP INC
ID-US12-BUP
In Commercial Distribution

  • 20850721007932 ()
  • 10850721007935 ()
  • 00850721007938 ()
ID-US12-BUP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The HarmonyAIR Hybrid High Definition Single Light, with Dual Flat Panel Monitor, 20-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995176099 ()
LEH56IN02T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Hybrid Single Light, with Dual Flat Panel Monitor, No Drop Tube, No Camera, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995176013 ()
LES56NCNDT

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Hybrid Single Light, with Dual Flat Panel Monitor, 20-inch Drop Tube, No Camera, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995176006 ()
LES56NC02T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Hybrid Single Light, with Dual Flat Panel Monitor, 13-inch Drop Tube, No Camera, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175993 ()
LES56NC01T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR E-Series High Definition Single Light, with Dual Flat Panel Monitor, No Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175504 ()
LEH11INNDT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The G5 Dual Light with Single Flat Panel Monitor Mount, High Density Camera Ready, Single Cardanic with Tandem and Wall Control is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995192426 ()
LGH42T

  • Operating room light system
  • Medical monitor/light mount
  • Operating room light
The HarmonyAIR Hybrid High Definition Single Light, with Dual Flat Panel Monitor, No Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995176105 ()
LEH56INNDT

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Hybrid High Definition Single Light, with Dual Flat Panel Monitor, 13-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995176082 ()
LEH56IN01T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR E-Series High Definition Single Light, with Dual Flat Panel Monitor, No Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175740 ()
LEH13INNDT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR E-Series High Definition Single Light, with Dual Flat Panel Monitor, 20-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175733 ()
LEH13IN02T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR E-Series High Definition Single Light, with Dual Flat Panel Monitor, 13-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175726 ()
LEH13IN01T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR E-Series High Definition Single Light, with Dual Flat Panel Monitor, 20-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175498 ()
LEH11IN02T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR E-Series High Definition Single Light, with Dual Flat Panel Monitor, 13-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175481 ()
LEH11IN01T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single High Definition Light 35-inch with Single Flat Panel Monitor, No Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173463 ()
LEH04INNDT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single High Definition Light 35-inch with Single Flat Panel Monitor, 20-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173456 ()
LEH04IN02T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single High Definition Light 35-inch with Single Flat Panel Monitor, 13-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173449 ()
LEH04IN01T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR E-Series High Definition Dual Light with Single Flat Panel Monitor, No Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172749 ()
LEH02INNDT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR E-Series High Definition Dual Light with Single Flat Panel Monitor, 20-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172732 ()
LEH02IN02T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR E-Series High Definition Dual Light with Single Flat Panel Monitor, 13-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172725 ()
LEH02IN01T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single High Definition Light 35-inchwith Single Flat Panel Monitor, 20-inch 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

  • 00724995173425 ()
LEH04NC02

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single High Definition Light 35-inchwith Single Flat Panel Monitor, 13-inch 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

  • 00724995173418 ()
LEH04NC01

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light 43-inch with Single Flat Panel Monitor, 13-inch Drop Tube, No Camera, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173357 ()
LES24NC01T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR E-Series High Definition Single Light 43-inchwith Single Flat Panel Monitor, No Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173227 ()
LEH24INNDT

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR E-Series High Definition Single Light 43-inch with Single Flat Panel Monitor, 20-inch Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173159 ()
LEH24IN02

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Opiates, Methamphetamine, Cocaine, Phencyclidine, Amphetamine, Benzodiazepines, Methadone, and Oxycodone drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
605105
Not in Commercial Distribution

  • 00690286000469 ()
  • 10690286000466 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Opiates, Methamphetamine, Cocaine, Phencyclidine, Amphetamine, Benzodiazepines, Methadone, and Oxycodone drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
605100
In Commercial Distribution

  • 10690286000411 ()
  • 00690286000414 ()


  • 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, and Benzodiazepines drugs and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601591
In Commercial Distribution

  • 10690286000275 ()
  • 00690286000278 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Opiates, Amphetamine, Benzodiazepines, Tricyclic Antidepressants, Methadone, and Barbiturates drugs and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
604019
In Commercial Distribution

  • 10690286000022 ()
  • 00690286000025 ()


  • Multiplex analyser IVD, laboratory
  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The Rapid Seal Model SE330 is a standard bench-top tube sealer with fixed sealing head for high volume use. The device has a sealing head on the front panel.
CENTRON CORPORATION
SE330
In Commercial Distribution

  • 08809241441229 ()

  • Weight: 5 Kilogram
  • Width: 17.6 Centimeter
  • Height: 15.6 Centimeter
  • Depth: 33.1 Centimeter
SE330

  • Blood donor bag tube divider/sealer
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
X-MIND trium PAN version including one PAN sensor, with control panel on the left side including one removable ceph sensor configurated for installation of ceph arm on the right
DE GÖTZEN SRL
XMT PAN L CEPH READY R
Not in Commercial Distribution

  • D804W09000080 ()
W0900008

  • Stationary panoramic/tomographic dental x-ray system, digital
X-MIND trium PAN version including one PAN sensor, with control panel on the right side including one removable ceph sensor configurated for installation of ceph arm on the left
DE GÖTZEN SRL
XMT PAN R CEPH READY L
Not in Commercial Distribution

  • D804W09000020 ()
W0900002

  • Cone beam computed tomography system, head/neck
  • Stationary panoramic/tomographic dental x-ray system, digital
U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR/pH/OX/SG/Ni) 11 Panel Drug Test Cup(AMP500/BAR300/BZO300/BUP10/THC50/COC150/MTD300/MET500/MDMA500/MOP300/OXY100)
Instant Technologies, Inc.
USSCupA-11CLIALC
In Commercial Distribution

  • 00817405021376 ()
  • 10817405021373 ()
USSCupA-11CLIALC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen™ Urine Test CLIA Waived DX Drug Screen Square Cup 10 panel with SVTs (AMP1000/BAR300/BZO300/COC300/MDMA500/MET1000/MOP300/OXY100/PCP25/THC50)+ SVT Cr, pH, S.G.
Instant Technologies, Inc.
ABTDUAW110704D
In Commercial Distribution

  • 10817405022226 ()
  • 00817405022229 ()
  • 30817405022220 ()
ABTDUAW110704D

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

  • 00812125010020 ()
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.
8025-300
In Commercial Distribution

  • 00816870021898 ()

  • Width: 7.75 Inch
8025-300D

  • Total triiodothyronine (TT3) 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
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.
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

  • 00816870022116 ()

  • Width: 12 Inch
8475-300D

  • Alpha-fetoprotein (AFP) IVD, kit, enzyme immunoassay (EIA)
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