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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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HarmonyAIR - 00724995175733

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

HarmonyAIR - 00724995175726

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

HarmonyAIR - 00724995175504

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

HarmonyAIR - 00724995175498

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

HarmonyAIR - 00724995175481

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

HarmonyAIR - 00724995176105

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

HarmonyAIR - 00724995176082

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

HarmonyAIR - 00724995176006

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

HarmonyAIR - 00724995173463

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

HarmonyAIR - 00724995173449

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

HarmonyAIR - 00724995173418

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

HarmonyAIR - 00724995173227

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

HarmonyAIR - 00724995173159

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

HarmonyAIR - 00724995172749

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

HarmonyAIR - 00724995172732

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

HarmonyAIR - 00724995172725

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

UScreen® - 10817405021373

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

Acuitas - 10812125010027

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 - D804W09000080

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 - D804W09000020

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

Identify Health - 10850721007997

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

Rapid Seal Tube Sealer SE330 - 08809241441229

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

Acuitas - 00812125010020

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

iScreen™ - 00817405022229

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

MAS omni Infectious BSI Positive Control Panel for use with Siemens Assays - 00884883007376

No Description
Microgenics Corporation
10027480-U
In Commercial Distribution

  • 00884883007376 ()


  • Multiple-type sexually transmitted pathogen nucleic acid IVD, control

AFP, CEA, PSA Cancer Panel AccuLite VAST CLIA Test System - 480 Wells - 00816870022116

No Description
MONOBIND, INC.
8475-300
In Commercial Distribution

  • 00816870022116 ()

  • Width: 12 Inch
8475-300D

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

AFP, CEA, PSA Cancer Panel AccuLite VAST CLIA Test System - 192 Wells - 00816870022109

No Description
MONOBIND, INC.
8475-300
In Commercial Distribution

  • 00816870022109 ()

  • Width: 7.75 Inch
8475-300B

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

Folate, Vit B12 Anemia Panel AccuLite VAST CLIA Test System - 96 Wells - 00816870021966

No Description
MONOBIND, INC.
7825-300
In Commercial Distribution

  • 00816870021966 ()

  • Width: 7.75 Inch
7825-300A

  • Folate (vitamin B9) IVD, kit, enzyme immunoassay (EIA)

T3, T4, TSH Thyroid Panel AccuBind VASTAccuBind ELISA Test System - 480 Wells - 00816870021898

No Description
MONOBIND, INC.
8025-300
In Commercial Distribution

  • 00816870021898 ()

  • Width: 7.75 Inch
8025-300D

  • Total triiodothyronine (TT3) IVD, kit, enzyme immunoassay (EIA)

AFP, CEA, PSA Cancer Panel AccuLite VAST CLIA Test System - 960 Wells - 00816870022123

No Description
MONOBIND, INC.
8475-300
In Commercial Distribution

  • 00816870022123 ()

  • Width: 12 Inch
8475-300E

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

T3, T4, TSH Thyroid Panel AccuBind VAST ELISA Test System - 192 Wells - 00816870021881

No Description
MONOBIND, INC.
8025-300
In Commercial Distribution

  • 00816870021881 ()

  • Width: 7.75 Inch
8025-300B

  • Total triiodothyronine (TT3) IVD, kit, enzyme immunoassay (EIA)

AFP, CEA, PSA Cancer Panel AccuBind VAST ELISA Test System - 960 Wells - 00816870020440

No Description
MONOBIND, INC.
8425-300
In Commercial Distribution

  • 00816870020440 ()

  • Width: 12 Inch
8425-300E

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

AFP, CEA, PSA Cancer Panel AccuBind VAST ELISA Test System - 480 Wells - 00816870020433

No Description
MONOBIND, INC.
8425-300
In Commercial Distribution

  • 00816870020433 ()

  • Width: 12 Inch
8425-300D

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

Folate, Vit B12 Anemia Panel AccuBind VAST ELISA Test System - 192 Wells - 00816870020297

No Description
MONOBIND, INC.
7875-300
In Commercial Distribution

  • 00816870020297 ()

  • Width: 7.75 Inch
7875-300B

  • Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay

Folate, Vit B12 Anemia Panel AccuBind VAST ELISA Test System - 96 Wells - 00816870020280

No Description
MONOBIND, INC.
7875-300
In Commercial Distribution

  • 00816870020280 ()

  • Width: 7.75 Inch
7875-300A

  • Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay

FLAT PANEL MONITOR, SELECT SIZE: 22"-31", SELECT COLOR: BLACK OR WHITE - 00810040251016

No Description
GLOBAL SURGICAL CORPORATION
M 547FS22
In Commercial Distribution

  • 00810040251016 ()


  • General-purpose surgical microscope

EZ-SCREEN® CUP - 00690286000520

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

PROFILE®-IIA - 00690286000308

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

HarmonyAIR - 00724995173470

The HarmonyAIR Single High Definition Light 35-inchwith 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

  • 00724995173470 ()
LEH04NC01T

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

Rapid Response - 00722066003459

Rapid Response Multi Drug Test Panel (COC/AMP/MET/THC/OPI/MDMA) - 25 tests/ kit are for qualitative detection of Amphetamine, Methamphetamine, Opiates, 3,4-Methyoxydiene-Methamphetamine, Cocaine and THC metabolites in urine.
BTNX Inc
D6.14-1P29-25
In Commercial Distribution

  • 00722066003459 ()
  • 00722066004012 ()
D6.14-1P29-25

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

Alpine BioMed - 05704736017282

"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

Alpine BioMed - 05704736017268

"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

Alpine BioMed - 05704736017794

"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

Alpine BioMed - 05704736017275

"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

Alpine BioMed - 05704736017251

"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

Alpine BioMed - 05704736017206

"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

PROFILE®-V MEDTOXScan® - 00690286000056

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

HarmonyAIR - 00724995176075

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

HarmonyAIR - 00724995175719

The HarmonyAIR E-Series 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

  • 00724995175719 ()
LEH13NCND

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

HarmonyAIR - 00724995175702

The HarmonyAIR E-Series High Definition Single Light, with Dual 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

  • 00724995175702 ()
LEH13NC02

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