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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 - 00724995175528

The HarmonyAIR E-Series High Definition 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

  • 00724995175528 ()
LEH11NC02T

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

HarmonyAIR - 00724995175511

The HarmonyAIR E-Series High Definition 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

  • 00724995175511 ()
LEH11NC01T

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

HarmonyAIR - 00724995176112

The HarmonyAIR Hybrid High Definition 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

  • 00724995176112 ()
LEH56NC01T

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

HarmonyAIR - 00724995172770

The HarmonyAIR E-Series High Definition Dual Light with Single 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

  • 00724995172770 ()
LEH02NCNDT

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

HarmonyAIR - 00724995172763

The HarmonyAIR E-Series High Definition Dual Light with Single 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

  • 00724995172763 ()
LEH02NC02T

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

HarmonyAIR - 00724995172756

The HarmonyAIR E-Series High Definition Dual Light 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

  • 00724995172756 ()
LEH02NC01T

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

T-Cup® Compact - 10817405021298

UScreen Squared Integrated CLIA Waived Cup with Adulterants (CR/NI/pH/OX/SG) 14 Panel Drug Screen (AMP500/BAR/BUP/BZO/COC150/MDMA/MET500/MOP/MTD/OXY/PCP/PPX/TCA/THC)
Instant Technologies, Inc.
USSCUPA-14CLIALC
In Commercial Distribution

  • 10817405021298 ()
USSCUPA-14CLIALC

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

ProMax Surgical Gown - 00634916819038

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, Size XL
STANDARD TEXTILE CO., INC.
75615074
In Commercial Distribution

  • 10634916819035 ()
  • 00634916819038 ()


  • Surgical gown, reusable

ProMax Surgical Gown - 00634916819021

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, Size Large
STANDARD TEXTILE CO., INC.
75615075
In Commercial Distribution

  • 10634916819028 ()
  • 00634916819021 ()


  • Surgical gown, reusable

QuickProfile™ Drugs of Abuse Test Cup - M90174046II0

Immunoassay for the detection of the following drug substance(s) in human urine: Selection of panel numbers between 1 to 9 from AMP / BAR / BZD / COC / M-AMP / MTD / OPI / PCP / THC
LUMIQUICK DIAGNOSTICS, INC.
74046-II
In Commercial Distribution

  • M90174046II0 ()
  • M90174046II1 ()

  • Length: 74 Millimeter
74046-II

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

Blue Diamond - 15060797552306

Patient Restraint Strap made of fiber reinforced rubber. Has a foam mid panel with two airplane style buckles to adjust strap length. Conductive and latex free. Extremely durable and easily cleaned
David Scott Company
BD800
In Commercial Distribution

  • 15060797552306 ()

  • Width: 2 Inch
  • Length: 96 Inch
BD800

  • Medical table restraint anchor

THE SENSITITRE AIM - 00848838097409

The Sensititre Autoinoculator 2, AIM™ instrument is an automated pipette system for the delivery of user prepared inoculated media in multiples of 50 and 100 µl into the Sensititre 96 well antimicrobial susceptibility plate. The AIM™ is a bench-top instrument which dispenses bacterial suspension (inoculum) into a 96-well plate (MIC panel). The instrument has a display which presents options to the user graphically. The user may then select the well dose volume (a multiple of 50 µl) specific to each panel section. Different panel sections may be dosed differently. After selection of these parameters, the user loads the inoculum tube, a suitable panel and then starts the dosing cycle. The AIM™ is a stand-alone device and requires no connections to other equipment in normal use. It currently provides no support for sample tracking.
REMEL, INC.
V3020
In Commercial Distribution

  • 00848838097409 ()


  • Antimicrobial susceptibility analyser IVD

PROFILE®-IIA - 00690286000773

A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamine, Cocaine, Phencyclidine, Barbiturates, Benzodiazepines, Methamphetamine (MAMP), 3,4-Methylenedioxymethamphetamine (MDMA), and Oxycodone drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601683
In Commercial Distribution

  • 10690286000770 ()
  • 00690286000773 ()


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

PROFILE®-V MEDTOXScan® - 00690286000759

A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Methamphetamine (MAMP), Opiates, Amphetamine, Benzodiazepines, Tricyclic Antidepressants, Methadone, Barbiturates, and Oxycodone drugs and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
604031
In Commercial Distribution

  • 10690286000756 ()
  • 00690286000759 ()


  • Multiplex analyser IVD, laboratory
  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

SURE-SCREEN® - 00690286000407

A qualitative one-step immunochromatographic test panel for the detection of Amphetamine, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Methamphetamine, Methadone, Opiates, Oxycodone, Phencyclidine, Propoxyphene, and THC (cannabinoids) drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
600723
Not in Commercial Distribution

  • 10690286000404 ()
  • 00690286000407 ()


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

Welch Allyn, Inc. - 00732094137019

Welch Allyn 767 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), Coaxial Ophthalmoscope (#11720), Pneumatic Otoscope (#20200), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm)
WELCH ALLYN, INC.
901027
Not in Commercial Distribution

  • 00732094137019 ()
76798

  • Basic power supply, reusable

Alpine BioMed - 05704736017244

"Keypoint Focus Workstation, FRA Including: - USFF PC with Keypoint software, MS Office, 22” display - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - Cart with isolating power supply - System kit"
Alpine Biomed ApS
9033A072102
Not in Commercial Distribution

  • 05704736017244 ()


  • Electromyograph

Alpine BioMed - 05704736017237

"Keypoint Focus Workstation, Intl. 230V (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
9033A072101
Not in Commercial Distribution

  • 05704736017237 ()


  • Electromyograph

Alpine BioMed - 05704736017220

"Keypoint Focus Workstation, Intl. 115V (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
9033A0721HA
Not in Commercial Distribution

  • 05704736017220 ()


  • Electromyograph

Welch Allyn, Inc. - 00732094067828

Welch Allyn 767 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), Coaxial Ophthalmoscope (#11720), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); IEC Plug Type-B
WELCH ALLYN, INC.
901027
Not in Commercial Distribution

  • 00732094067828 ()
76796-M

  • Basic power supply, reusable

Welch Allyn, Inc. - 00732094069426

Welch Allyn 767 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), Standard Ophthalmoscope (#11710), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (40 x 12 in / 101.6 x 30.5 cm)
WELCH ALLYN, INC.
901027
Not in Commercial Distribution

  • 00732094069426 ()
76782-M

  • Basic power supply, reusable

Blue Diamond - 15060797552122

Blue Diamond® Patient Restraint Strap is tradtional 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
BD2620
In Commercial Distribution

  • 15060797552122 ()

  • Width: 5 Inch
  • Length: 96 Inch
  • Height: .375 Inch
BD2620

  • Operating table patient pressure distribution pad, reusable

AFP, hCG, uE3 Triple Screen Panel AccuLite VAST CLIA Test System - 480 Wells - 00816870022550

No Description
MONOBIND, INC.
8575-300
In Commercial Distribution

  • 00816870022550 ()

  • Width: 12 Inch
8575-300D

  • Trisomy 21-risk hormone IVD, kit, chemiluminescent immunoassay

T3, T4, TSH Thyroid Panel AccuBind VAST AccuBind ELISA Test System - 2592 Wells - 00816870021911

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

  • 00816870021911 ()

  • Width: 7.75 Inch
8025-300G

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

T3, T4, TSH Thyroid Panel AccuBind VAST AccuBind ELISA Test System - 960 Wells - 00816870021904

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

  • 00816870021904 ()

  • Width: 7.75 Inch
8025-300E

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

AFP, hCG, uE3 Triple Screen Panel AccuBind VAST ELISA Test System - 96 Wells - 00816870021843

No Description
MONOBIND, INC.
8525-300
In Commercial Distribution

  • 00816870021843 ()

  • Width: 7.75 Inch
8525-300A

  • Trisomy 21-risk hormone IVD, kit, enzyme immunoassay (EIA)

AFP, hCG, uE3 Triple Screen Panel AccuBind VAST ELISA Test System - 480 Wells - 00816870020891

No Description
MONOBIND, INC.
8525-300
In Commercial Distribution

  • 00816870020891 ()

  • Width: 12 Inch
8525-300D

  • Trisomy 21-risk hormone IVD, kit, enzyme immunoassay (EIA)

AFP, hCG, uE3 Triple Screen Panel AccuBind VAST ELISA Test System - 192 Wells - 00816870020884

No Description
MONOBIND, INC.
8525-300
In Commercial Distribution

  • 00816870020884 ()

  • Width: 7.75 Inch
8525-300B

  • Trisomy 21-risk hormone IVD, kit, enzyme immunoassay (EIA)

T3, T4, TSH Thyroid Panel AccuLite VAST AccuLite CLIA Test System - 960 Wells - 00816870023342

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

  • 00816870023342 ()

  • Width: 7.75 Inch
8075-300E

  • Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay

T3, T4, TSH Thyroid Panel AccuLite VAST AccuLite CLIA Test System - 480 Wells - 00816870023335

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

  • 00816870023335 ()

  • Width: 7.75 Inch
8075-300D

  • Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay

AFP, hCG, uE3 Triple Screen Panel AccuLite VAST CLIA Test System - 96 Wells - 00816870023281

No Description
MONOBIND, INC.
8575-300
In Commercial Distribution

  • 00816870023281 ()

  • Width: 7.75 Inch
8575-300A

  • Trisomy 21-risk hormone IVD, kit, chemiluminescent immunoassay

MicroScan - 15099590702724

LabPro Connect software is an option for laboratories with multiple instruments and workstations in a networked environment to improve workflow efficiency, data processing and storage, and to increase throughput. With LabPro Connect software, you can access all results data from any MicroScan instrument on the LabPro network and perform most daily tasks (for example, ordering panels, printing barcode labels, viewing panel results, resolving panel processing alerts, and transmitting test results).
Beckman Coulter, Inc.
V5.0
In Commercial Distribution

  • 15099590702724 ()
  • 15099590702793 ()
C24147

  • Microorganism identification/antimicrobial-susceptibility analyser IVD

PROFILE®-V MEDTOXScan® - 00690286000766

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

PROFILE®-IIA - 00690286000360

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

PROFILE-II ER® - 00690286000285

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

PROFILE®-V MEDTOXScan® - 00690286000018

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

STEPHANIX - 03664049001052

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

STEPHANIX - 03664049000062

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

STEPHANIX - 03664049000048

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

STEPHANIX - 03664049001069

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

STEPHANIX - 03664049001045

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

STEPHANIX - 03664049001038

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

STEPHANIX - 03664049000055

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

STEPHANIX - 03664049000031

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

Acuitas - 01812125010005

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

ComPel Surgical Gown - 00634916691641

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 Surgical Gown - 00634916348491

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

ComPel OR Gown - 00634916788358

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

Acuitas - 20812125010000

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

PRC Look™ - 00858526006712

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
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