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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FDA Clia Waived, AMP500/BAR300/BZO300/BUP10/COC150/THC50/MTD300/MET500/MDMA500/MOP300/PCP25/TCA1000/OXY100/FYL1)+(OXI/CRE/pH)
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 16936983165522 ()
  • 06936983165525 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
FDA Clia Waived, AMP500/BAR300/BZO300/BUP10/COC150/THC50/MTD300/MET500/MDMA500/MOP300/PCP25/TCA1000/OXY100/FYL1
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 16936983165478 ()
  • 06936983165471 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
FDA Clia Waived, AMP500/BAR300/BZO300/BUP10/COC150/THC50/MTD300/MET500/MDMA500/MOP300/PCP25/TCA1000/OXY100/FYL1
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 16936983165454 ()
  • 06936983165457 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
EQ 12 PANEL DRG TEST
WAL-MART STORES, INC.
572627460
In Commercial Distribution

  • 00681131089869 ()


  • Opiate/opiate metabolite IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Methadone IVD, reagent
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Oxycodone IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Nortriptyline IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
D13.5-1V- OPI300 MDMA500 OXY100 PCP25 MTD300 BAR300 BZO300 COC150 AMP500 MET500 THC50 BUP10 FYL1
BTNX Inc
D13.5-1V
In Commercial Distribution

  • 00722066009079 ()
  • 10722066009076 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
AMERICAN SCREENING, L.L.C.
PREDX-DOA-764N
In Commercial Distribution

  • 00840050512920 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 12 Panel Dip -KCUR920124 AMP1000/BAR300/BZO300/COC300/MDMA500/MET1000/MTD300/OPI2000/OXY100/PCP25/PPX300/THC50
CLINICAL REFERENCE LABORATORY, INC.
KCUR920124
In Commercial Distribution

  • 00817815021447 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 11 panel Dip - KCUR920084 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/OXY100/PCP25/PPX300/THC50 & (pH/SG/OX)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920084
In Commercial Distribution

  • 00817815021140 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 11 Panel Cup- KCUR920082 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/OXY100/PCP25/PPX300/THC50 (pH/SG/OX/CR/NI)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920082
In Commercial Distribution

  • 00817815020877 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 12 Panel Dip -KCUR920124 AMP1000/BAR300/BZO300/COC300/MDMA500/MET1000/MTD300/OPI2000/OXY100/PCP25/PPX300/THC50
CLINICAL REFERENCE LABORATORY, INC.
KCUR920124
In Commercial Distribution

  • 00817815020778 ()
  • 00817815020785 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 11 panel Dip - KCUR920084 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/OXY100/PCP25/PPX300/THC50 & (pH/SG/OX)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920084
In Commercial Distribution

  • 00817815020693 ()
  • 00817815020709 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Test Panels (COC/AMP/MET/MDMA/THC/MTD/MOPI/OXY/BAR/BZO/PCP/PPX) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Methadone, Opiates, Oxycodone, Barbiturates, Benzodiazepines, Cocaine, THC, Phencyclidine and Propoxyphene metabolites in urine.
BTNX Inc
D12.8.1-1P29-25
In Commercial Distribution

  • 00722066005361 ()
  • 10722066005368 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Healgen (DrugConfirm) - 12-panel Clicker Cup Test with Low Cutoff: AMP500/BAR300/BZO300/COC150/mAMP500/MDMA500/MOP300/MTD300/OXY100/PCP25/PPX300/THC50/ Adulterants (CR/SG/OX)
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-1125SA3C
In Commercial Distribution

  • 00895330002578 ()


  • Cocaine/cocaine metabolite IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, reagent
  • Oxycodone IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Methadone IVD, reagent
Healgen (DrugConfirm) - 12 Panel Clicker Cup Test: AMP1000/BAR300/BUP10/BZO300/COC300/MDMA500/MTD300/MOP2000/OXY100/PCP25/TCA1000/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-3124
In Commercial Distribution

  • 00895330002547 ()


  • Opiate/opiate metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Nortriptyline IVD, reagent
  • Benzodiazepine group IVD, reagent
  • Oxycodone IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Methadone IVD, reagent
No Description
Shenzhen Bioeasy Biotechnology Co., Ltd
U-Catch XR Multi-Drug Test Cup
In Commercial Distribution

  • 06972428161691 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
Shenzhen Bioeasy Biotechnology Co., Ltd
U-Catch XR Multi-Drug Test Cup
In Commercial Distribution

  • 06972428161790 ()
BXU4105-A3(4)

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
Shenzhen Bioeasy Biotechnology Co., Ltd
U-Catch PLUS Multi-Drug Test Cup
In Commercial Distribution

  • 06972428161738 ()
BPU6125-A3(1)

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
Shenzhen Bioeasy Biotechnology Co., Ltd
U-Catch XR Multi-Drug Test Cup
In Commercial Distribution

  • 06972428161363 ()
BXU6125

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
Shenzhen Bioeasy Biotechnology Co., Ltd
U-Catch PLUS Multi-Drug Test Cup
In Commercial Distribution

  • 06972428161110 ()
YRLG02801025-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
Shenzhen Bioeasy Biotechnology Co., Ltd
U-Catch PLUS Multi-Drug Test Cup
In Commercial Distribution

  • 06972428160786 ()
YRLG02801005

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
MOP(OPI)300/MDMA500/OXY100/PCP25/COC150/MET500/MTD300/BAR300/BZO300/AMP500/TCA1000/THC50
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 06936983167611 ()
  • 16936983167618 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
FDA Clia Waived, MOP(OPI)300/MDMA500/OXY100/PCP25/COC150/MET500/MTD300/BAR300/BZO300/AMP500/TCA1000/THC50/BUP10
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 06936983165723 ()
  • 16936983165720 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
L-Cup Home Rapid Test (Urine). For the rapid detection of the following drugs in human urine: AMP500 BAR300 BUP10 BZO300 COC150 MDMA500 MTD300 MET500 MOP2000 OXY100 THC50 PCP25
BTNX Inc
D12.5.1-1VL
In Commercial Distribution

  • 10722066006747 ()
  • 00722066006740 ()
  • 20722066006744 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
One Step 10 Panel DOA Cup (10.14.1) - COC150 AMP500 MET500 THC50 MTD300 MOP2000 OXY100 PCP25 BAR300 BZO300
BTNX Inc
D10.14.1-1V
In Commercial Distribution

  • 00722066004890 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
One Step 12 Panel DOA Cup (12.5.1) - AMP500 BAR300 BUP10 BZO300 COC150 MDMA500 MTD300 MET500 MOP2000 OXY100 THC50 PCP25
BTNX Inc
D12.5.1-1V
In Commercial Distribution

  • 00722066004876 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi-Drug One Step Cup - AMP1000 BAR300 BUP10 BZO300 COC300 MDMA500 MTD300 MET1000 OPI2000 OXY100 THC50 TCA1000
BTNX Inc
D12.21-1V
In Commercial Distribution

  • 00722066004722 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The easiest way to provide an individual with four side-by-side communication choices is with the iTalk4 speech device. Activate the colored top to play the desired message. New messages are easily and quickly recorded to the iTalk4 on the fly, or use the levels pre-record up to three sets of messages ahead of time. Includes ableCARE on-demand support Built ableSTRONG to endure drops and other environmental conditions Made from ableSAFE materials and tested by third-party safety labs Common Uses Provide a unique response to a question like "What is the weather like outside?" Respond to an assessment Provide a way to make unique requests like "I need help", "I'm done", "I need to use the bathroom", and "I'm thirsty" Add communication to a switch controlled toy or appliance Features Better than ever digital sound output suitable for almost any environment Clear snap cover to attach picture symbols and provide communication context to the user Symbol Overlays Symbol overlays are not included with the iTalk4. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.
Ablenet, Inc.
10000028
In Commercial Distribution

  • 00186648000531 ()
10000028

  • Assistive speech generator
This submission includes two assisted reproduction laser systems, the LaserShot M and the NaviLase. The LaserShot M is a static laser system where the embryo is moved to the laser by moving the stage of the microscope. The LaserShot M components include a laser module (1.48 micrometer infrared diode laser, class 1M), laser adapter to connect to the microscope, mirror block, laser objective (25X), USB camera, EyeWare Software, and an optional target pointer and footswitch. The NaviLase includes the same components as the LaserShot M, but also includes a motion module and a motion controller. These additional components allow the NaviLase to work in two modes, fixed and dynamic. In fixed mode, the NaviLase operates similarly to the LaserShot M. In dynamic mode, the laser can be directed to any location within the field of view. In addition, dynamic mode allows automated laser firing along a user-defined path (straight line, arc, etc.). The EyeWare software controls the device components, operates the laser, and takes images and records videos of embryo undergoing laser procedures. The software determines how many holes are drilled along this line and controls/restricts laser firing parameters to minimize localized heating of the embryo during these procedures. These laser devices have been designed to be fitted to compatible inverted microscopes.
Octax Microscience GmbH
19310/0146
In Commercial Distribution

  • 04260604170028 ()
19310/0146

  • Assisted reproduction laser system
Conformer is temporarily implanted between the eye ball and the eye lid to protect sutures and to prevent adhesion of the eye lid onto the eye sac. The Conformer also prevents the orbital socket from closing in on itself during the healing process and forces the muscles to conform around it.
Gulden Ophthalmics Inc.
14166
In Commercial Distribution

  • B091141661 ()
  • B091141660 ()

  • Width: 0.98 Inch
  • Length: 0.87 Inch
14166

  • Ophthalmic conformer
Conformer is temporarily implanted between the eye ball and the eye lid to protect sutures and to prevent adhesion of the eye lid onto the eye sac. The Conformer also prevents the orbital socket from closing in on itself during the healing process and forces the muscles to conform around it.
Gulden Ophthalmics Inc.
14165
In Commercial Distribution

  • B091141651 ()
  • B091141650 ()

  • Width: 0.94 Inch
  • Length: 0.83 Inch
14165

  • Ophthalmic conformer
Conformer is temporarily implanted between the eye ball and the eye lid to protect sutures and to prevent adhesion of the eye lid onto the eye sac. The Conformer also prevents the orbital socket from closing in on itself during the healing process and forces the muscles to conform around it.
Gulden Ophthalmics Inc.
14164
In Commercial Distribution

  • B091141641 ()
  • B091141640 ()

  • Width: 0.87 Inch
  • Length: 0.75 Inch
14164

  • Ophthalmic conformer
The HidraWear BB Women’s Briefs device is a garment device, which is intended for the retention of a dressing in the buttocks and groin area. The HidraMed BB Women’s Briefs is a garment device designed to remove the requirement to attach the dressing to the skin. The garment is worn underneath or in place of regular underwear and then a dressing is applied to the buttocks and groin area. A fastening mechanism such as tape is used to attach the dressing to the garment. The device is intended to be used by a home user that requires routine wound care. Size: Extra Large
HIDRAMED SOLUTIONS LIMITED
GBB001-04
In Commercial Distribution

  • 05391535510313 ()


  • Non-adhesive device retention bandage
The HidraWear BB Women’s Briefs device is a garment device, which is intended for the retention of a dressing in the buttocks and groin area. The HidraMed BB Women’s Briefs is a garment device designed to remove the requirement to attach the dressing to the skin. The garment is worn underneath or in place of regular underwear and then a dressing is applied to the buttocks and groin area. A fastening mechanism such as tape is used to attach the dressing to the garment. The device is intended to be used by a home user that requires routine wound care. Size: Large
HIDRAMED SOLUTIONS LIMITED
GBB001-03
In Commercial Distribution

  • 05391535510306 ()


  • Non-adhesive device retention bandage
The HidraWear BB Women’s Briefs device is a garment device, which is intended for the retention of a dressing in the buttocks and groin area. The HidraMed BB Women’s Briefs is a garment device designed to remove the requirement to attach the dressing to the skin. The garment is worn underneath or in place of regular underwear and then a dressing is applied to the buttocks and groin area. A fastening mechanism such as tape is used to attach the dressing to the garment. The device is intended to be used by a home user that requires routine wound care. Size: Medium
HIDRAMED SOLUTIONS LIMITED
GBB001-02
In Commercial Distribution

  • 05391535510290 ()


  • Non-adhesive device retention bandage
The HidraWear BB Women’s Briefs device is a garment device, which is intended for the retention of a dressing in the buttocks and groin area. The HidraMed BB Women’s Briefs is a garment device designed to remove the requirement to attach the dressing to the skin. The garment is worn underneath or in place of regular underwear and then a dressing is applied to the buttocks and groin area. A fastening mechanism such as tape is used to attach the dressing to the garment. The device is intended to be used by a home user that requires routine wound care. Size: Small
HIDRAMED SOLUTIONS LIMITED
GBB001-01
In Commercial Distribution

  • 05391535510283 ()


  • Non-adhesive device retention bandage
The HidraWear AX T-shirt device is a garment device, which is intended for the retention of a dressing in the axillar area. The HidraMed AX T-shirt is a garment device designed to remove the requirement to attach the dressing to the skin. The garment is worn under a shirt or in place of a regular t-shirt and then a dressing is applied to the axillar area. A fastening mechanism such as tape is used to attach the dressing to the garment. The device is intended to be used by a home user that requires routine wound care. Size: Extra Extra Large
HIDRAMED SOLUTIONS LIMITED
GAX002-05
In Commercial Distribution

  • 05391535510221 ()


  • Non-adhesive device retention bandage
The HidraWear AX T-shirt device is a garment device, which is intended for the retention of a dressing in the axillar area. The HidraMed AX T-shirt is a garment device designed to remove the requirement to attach the dressing to the skin. The garment is worn under a shirt or in place of a regular t-shirt and then a dressing is applied to the axillar area. A fastening mechanism such as tape is used to attach the dressing to the garment. The device is intended to be used by a home user that requires routine wound care. Size: Extra Large
HIDRAMED SOLUTIONS LIMITED
GAX002-04
In Commercial Distribution

  • 05391535510214 ()


  • Non-adhesive device retention bandage
The HidraWear AX T-shirt device is a garment device, which is intended for the retention of a dressing in the axillar area. The HidraMed AX T-shirt is a garment device designed to remove the requirement to attach the dressing to the skin. The garment is worn under a shirt or in place of a regular t-shirt and then a dressing is applied to the axillar area. A fastening mechanism such as tape is used to attach the dressing to the garment. The device is intended to be used by a home user that requires routine wound care. Size: Large
HIDRAMED SOLUTIONS LIMITED
GAX002-03
In Commercial Distribution

  • 05391535510207 ()


  • Non-adhesive device retention bandage
The HidraWear AX T-shirt device is a garment device, which is intended for the retention of a dressing in the axillar area. The HidraMed AX T-shirt is a garment device designed to remove the requirement to attach the dressing to the skin. The garment is worn under a shirt or in place of a regular t-shirt and then a dressing is applied to the axillar area. A fastening mechanism such as tape is used to attach the dressing to the garment. The device is intended to be used by a home user that requires routine wound care. Size: Medium
HIDRAMED SOLUTIONS LIMITED
GAX002-02
In Commercial Distribution

  • 05391535510191 ()


  • Non-adhesive device retention bandage
The HidraWear AX T-shirt device is a garment device, which is intended for the retention of a dressing in the axillar area. The HidraMed AX T-shirt is a garment device designed to remove the requirement to attach the dressing to the skin. The garment is worn under a shirt or in place of a regular t-shirt and then a dressing is applied to the axillar area. A fastening mechanism such as tape is used to attach the dressing to the garment. The device is intended to be used by a home user that requires routine wound care. Size: Small
HIDRAMED SOLUTIONS LIMITED
GAX002-01
In Commercial Distribution

  • 05391535510184 ()


  • Non-adhesive device retention bandage
Upgrade to the Adventurer + Bleeding & CPR Basic Kit with high-quality emergency items such as the SWAT-Tourniquet and a CPR face shield to address major life-threatening bleeding and cardiac arrest. The Bleeding & CPR Basic Kit comes inside the Minimalist Bag and is designed to attach to the inside of the Adventurer Kit.
Altitude Technologies Inc.
01424BC
In Commercial Distribution

  • 00850018201414 ()
01424BC

  • First aid kit, medicated
actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain. The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient. The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery. The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric. The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program. The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals. It is available for prescription only.
SUBLIMED
actiTENS standard kit
In Commercial Distribution

  • 03770018808239 ()
SBM1AA018

  • Analgesic transcutaneous electrical nerve stimulation system
actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain. The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient. The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery. The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric. The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program. The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals. It is available for prescription only.
SUBLIMED
actiTENS iOS app
In Commercial Distribution

  • B786SBM2AA2100 ()
SBM2AA210

  • Analgesic transcutaneous electrical nerve stimulation system
actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain in people. The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient. The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery. The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric. The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program. The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals. It is available for prescription only.
SUBLIMED
actiTENS Android app
In Commercial Distribution

  • B786SBM2AA1100 ()
SBM2AA110

  • Analgesic transcutaneous electrical nerve stimulation system
actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain. The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient. The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery. The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric. The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program. The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals. It is available for prescription only.
SUBLIMED
actiTENS
In Commercial Distribution

  • B786SBM1AA1100 ()
SBM1AA110

  • Analgesic transcutaneous electrical nerve stimulation system
actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain. The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient. The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery. The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric. The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program. The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals. It is available for prescription only.
SUBLIMED
actiTENS standard kit
In Commercial Distribution

  • B786SBM1AA0170 ()
SBM1AA017

  • Analgesic transcutaneous electrical nerve stimulation system
A convenience kit consisting of 15 Digital Ovulation Tests, Digital Basal Thermometer and 3 month subscription to Natural Cycles app
SPD SWISS PRECISION DIAGNOSTICS GMBH
Birth Control Kit
In Commercial Distribution

  • 10633472602372 ()
  • 00633472602375 ()
N/A

  • Natural conception assistance kit
The Scopis Hybrid Navigation System EM utilizes the Field Generator planar to create the electromagnetic field for navigation of surgical instruments. The EM Field Generator planar is connected to a mounting arm for placement close to the surgical area.
Scopis GmbH
1.0
In Commercial Distribution

  • B057U3010010 ()
U3 010 01

  • Patient positioning sensor
The ASP POD is intended to be used only with the ASP Device, ASP System, and ROSE Prep Pro - DI number: 00860008222404. The ASP POD is used to hold the sample that is to be deposited onto the slide.
ASP Health Inc.
A-03
In Commercial Distribution

  • 20860008222415 ()
  • 10860008222418 ()
PI-0077055

  • Microscope slide stainer IVD
15 strips, including MOR2000
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804802639 ()


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