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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 - 00724995173425

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

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 - 00724995173357

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

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

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

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

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

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

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

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

Accula Programming Cassette - B540D20010

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

Accula Dock - B540D20000

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

ProMax Surgical Gown - 00634916795493

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 - 00634916684926

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 - 00634916684919

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 - 00634916684896

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

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

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

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 - 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 - 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 - 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 - 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

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

HarmonyAIR - 00724995172718

The HarmonyAIR E-Series High Definition Dual Light with Single 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

  • 00724995172718 ()
LEH02NCND

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

HarmonyAIR - 00724995172701

The HarmonyAIR E-Series High Definition Dual Light with 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

  • 00724995172701 ()
LEH02NC02

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

HarmonyAIR - 00724995172695

The HarmonyAIR E-Series High Definition Dual Light with 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

  • 00724995172695 ()
LEH02NC01

  • 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

HarmonyAIR - 00724995175696

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

  • 00724995175696 ()
LEH13NC01

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

HarmonyAIR - 00724995175474

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

  • 00724995175474 ()
LEH11NCND

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

HarmonyAIR - 00724995175467

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

  • 00724995175467 ()
LEH11NC02

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

HarmonyAIR - 00724995175450

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

  • 00724995175450 ()
LEH11NC01

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

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 - 00724995176068

The HarmonyAIR Hybrid 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

  • 00724995176068 ()
LEH56NC02

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

HarmonyAIR - 00724995176051

The HarmonyAIR Hybrid High Definition Single Light, with Dual 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

  • 00724995176051 ()
LEH56NC01

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