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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The NEATCAP® DREAMIES® T-M device is a single use medical device designed to provide hearing protection for infants during air or ground hospital transport, or magnetic resonance imaging (MRI). The Size M device is designed for use on infants with a head circumference measuring 31-35cm. NEATCAP® DREAMIES® T-M devices are packaged non-sterile.
NEATCAP MEDICAL LLC
Size M
In Commercial Distribution

  • 00860008980724 ()
NEAT005-03

  • Infant acoustic earmuffs
The NEATCAP® DREAMIES® T-M device is a single use medical device designed to provide hearing protection for infants during air or ground hospital transport, or magnetic resonance imaging (MRI). The Size S device is designed for use on infants with a head circumference measuring 27-31cm. NEATCAP® DREAMIES® T-M devices are packaged non-sterile.
NEATCAP MEDICAL LLC
Size S
In Commercial Distribution

  • 00860008980717 ()
NEAT005-02

  • Infant acoustic earmuffs
The NEATCAP® DREAMIES® T-M device is a single use medical device designed to provide hearing protection for infants during air or ground hospital transport, or magnetic resonance imaging (MRI). The Size XS device is designed for use on infants with a head circumference measuring 23-27cm. NEATCAP® DREAMIES® T-M devices are packaged non-sterile.
NEATCAP MEDICAL LLC
Size XS
In Commercial Distribution

  • 00860008980700 ()
NEAT005-01

  • Infant acoustic earmuffs
No Description
Genabio Diagnostics Inc.
N/A
In Commercial Distribution

  • 00860008954817 ()
  • 86000895481700 ()
RA9-E02525

  • Multiple drugs of abuse IVD, control
No Description
Genabio Diagnostics Inc.
RA9-E02525
In Commercial Distribution

  • 00860008954800 ()
  • 10860008954807 ()
RA9-E02501

  • Multiple drugs of abuse IVD, control
Foldable Electric Wheelchair
Forcemech International LLC
NAVIGATOR XL
In Commercial Distribution

  • 00860008903693 ()


  • Wheelchair, electric-motor-driven, attendant/occupant-controlled, powered-steering, collapsible
Foldable Electric Wheelchair
Forcemech International LLC
NAVIGATOR
In Commercial Distribution

  • 00860008903686 ()


  • Wheelchair, electric-motor-driven, attendant/occupant-controlled, powered-steering, collapsible
Foldable Electric Wheelchair
Forcemech International LLC
VOYAGER R2
In Commercial Distribution

  • 00860008903624 ()


  • Wheelchair, electric-motor-driven, attendant/occupant-controlled, powered-steering, collapsible
Foldable Electric Wheelchair
Forcemech International LLC
NAVIGATOR EVO
In Commercial Distribution

  • 00860008903617 ()


  • Wheelchair, electric-motor-driven, attendant/occupant-controlled, powered-steering, collapsible
Premium Foldable Electric Wheelchair
Forcemech International LLC
CARBON F1
In Commercial Distribution

  • 00860008903600 ()


  • Wheelchair, electric-motor-driven, attendant/occupant-controlled, powered-steering, collapsible
Intraoral Optical Scanning System
Ori Inc
Ori One
In Commercial Distribution

  • 00860008859501 ()
10000

  • Intraoral optical scanning system
The PureLift Pro Edition device is a handheld device intended to apply electrical impulses to strategic locations on the face. The device probes are designed for optimal contact with the face. The device continually alternates between the positive and negative probes and allows the user to adjust the settings for personalized comfort level by pressing the up/down button. The intensity starts at (1) and continues to (10). These device measures 20.7cm (H) x 4.8cm (W) x 4.5cm (D).The outer case is injection molded of thermoplastic resin and the probes consist of chrome-plated spheres. The device is powered by a 3.7-volt battery which produces a low-level current that is transmitted through two fixed, smooth spherical probes. To turn the device on, the power button is pushed. Then the green LED light will illuminate indicating the unit is ready for use. Users then follow the instructions for use. The two probes gently glide over the skin to deliver low-level electrical impulses to strategic locations on the face with the use of conductive gel. The PureLift Pro Edition unit contains a power supply and rechargeable battery. The enclosure is made of medical grade biocompatible plastics and the output contacts (Probes) consist of chrome-plated spheres.
Xtreem Pulse LLC
PRO EDITION
In Commercial Distribution

  • 00860008851048 ()

  • Height: 20.7 Centimeter
  • Width: 4.8 Centimeter
  • Outer Diameter: 4.5 Centimeter
PURELIFT PRO EDITION

  • Facial muscle cosmesis electrical stimulator
The PureLift Pro Plus device is a handheld device intended to apply electrical impulses to strategic locations on the face. The device probes are designed for optimal contact with the face. The device continually alternates between the positive and negative probes and allows the user to adjust the settings for personalized comfort level by pressing the up/down button. The intensity starts at (1) and continues to (10). These device measures 20.7cm (H) x 4.8cm (W) x 4.5cm (D).The outer case is injection molded of thermoplastic resin and the probes consist of chrome-plated spheres. The device is powered by a 3.7-volt battery which produces a low-level current that is transmitted through two fixed, smooth spherical probes. To turn the device on, the power button is pushed. Then the green LED light will illuminate indicating the unit is ready for use. Users then follow the instructions for use. The two probes gently glide over the skin to deliver low-level electrical impulses to strategic locations on the face with the use of conductive gel. The PureLift Pro Plus unit contains a power supply and rechargeable battery. The enclosure is made of medical grade biocompatible plastics and the output contacts (Probes) consist of chrome-plated spheres.
Xtreem Pulse LLC
PRO PLUS
In Commercial Distribution

  • 00860008851031 ()

  • Height: 20.7 Centimeter
  • Width: 4.8 Centimeter
  • Outer Diameter: 4.5 Centimeter
PURELIFT PRO PLUS

  • Facial muscle cosmesis electrical stimulator
The PureLift Face device is a hand-held device intended to apply electrical impulses to strategic locations on the face. The probes are designed for optimal contact with the face. The device continually alternates between the positive and negative probes and allows the user to adjust the settings for personalized comfort level by pressing the up/down button. The intensity starts at (1) and continues to (10). The device, powered by a 3.7-volt battery, produces low-level current that is transmitted through the two fixed, smooth spherical probes. To turn the device on, the power button is pushed. Then the green LED light will illuminate indicating the unit is ready for use. The two probes gently glide over the skin to deliver low-level electrical impulses to strategic locations on the face with the use of conductive gel. The unit contains a power supply and rechargeable battery. The enclosure is made of medical grade biocompatible plastics and the output contacts (Probes) consist of chrome-plated spheres.
Xtreem Pulse LLC
FACE
In Commercial Distribution

  • 00860008851024 ()

  • Height: 1.4 Inch
  • Width: 4.8 Inch
  • Outer Diameter: 4.3 Inch
PURELIFT FACE

  • Facial muscle cosmesis electrical stimulator
The PureLift Pro device is a handheld device intended to apply electrical impulses to strategic locations on the face. The device probes are designed for optimal contact with the face. The device continually alternates between the positive and negative probes and allows the user to adjust the settings for personalized comfort level by pressing the up/down button. The intensity starts at (1) and continues to (10). These device measures 20.7cm (H) x 4.8cm (W) x 4.5cm (D).The outer case is injection molded of thermoplastic resin and the probes consist of chrome-plated spheres. The device is powered by a 3.7-volt battery which produces a low-level current that is transmitted through two fixed, smooth spherical probes. To turn the device on, the power button is pushed. Then the green LED light will illuminate indicating the unit is ready for use. Users then follow the instructions for use. The two probes gently glide over the skin to deliver low-level electrical impulses to strategic locations on the face with the use of conductive gel. The PureLift Pro unit contains a power supply and rechargeable battery. The enclosure is made of medical grade biocompatible plastics and the output contacts (Probes) consist of chrome-plated spheres.
Xtreem Pulse LLC
PRO
In Commercial Distribution

  • 00860008851017 ()

  • Height: 20.7 Centimeter
  • Width: 4.8 Centimeter
  • Outer Diameter: 4.5 Centimeter
PURELIFT PRO

  • Facial muscle cosmesis electrical stimulator
A disposable patch that temporarily adheres to the patient’s sternum, allowing for the housing of the Atlas Sensor
Atlas Lift Tech, Inc.
Rev A
In Commercial Distribution

  • 00860008806017 ()
  • 10860008806014 ()
  • 20860008806011 ()
  • 30860008806018 ()


  • Wearable multiple physiological parameter recorder, reusable
An electrically-powered computer-aided image-guided stereotactic system that typically consist of a mobile cart or carts, computer, 3D tracking system, surgical instruments that can be tracked, and application software for treatment planning and intraoperative navigation in cranial, ENT, and spine surgical procedures. Intraoperative navigation relies on individual or fused CT and MRI scans registered to the patient to allow the surgeon to correlate the position of navigated instruments used in surgery to the 3D images in real-time.
MED-SURGICAL SERVICES, INC.
90000
In Commercial Distribution

  • 00860008782700 ()


  • Multi-purpose stereotactic surgery system
The Know Rapid STD Screening Kit (Urine Test Cassette) includes individual test cassettes for: 1. Chlamydia Trachomatis (CHT) 2. Neisseria Gonorrhoeae (NGH) 3. Trichomonas Vaginalis (TV) 4. Mycoplasma Genitalium (MG). Each test strip in the cassette is suitable for urine specimen tests. During testing, if a specific antigen presented in the urine specimen reacts with each test cassette in the T reagent area, the conjugate antigens complex will be bound with the test cassette’s antibody coated on the membrane in case of a positive result. This would show in a dark red colored line in the T line region of a positive result. In case of negative result, no conjugate would bind at the test cassette’s antibody in the T line region and no line would form in the T line region of the test membrane. The C line serves as an internal qualitative control of the test system to indicate that an adequate volume of specimen has been applied and the flow occurred. Absence of C line indicates an invalid test result.
MobiLab Medical Innovatives Inc.
MSSH
Not in Commercial Distribution

  • 00860008737359 ()


  • Sexually transmitted infection (STI) testing specimen collection kit IVD, home-use
The MobiLab Standard Sexual Health Self Screening Kit (urine specimen) includes individual test cassettes for: 1. Trichomonas Vaginalis (TV) 2. Candida Albicans (Yeast) (CA) 3. Gardnerella Vaginalis (GV) 4. Mycoplasma Genitalium (MG) 5. Chlamydia Trachomatis (CHT) 6. Neisseria Gonorrhoeae (NGH). Each test strip in the cassette is suitable for urine specimen tests. During testing, if a specific antigen presented in the urine specimen reacts with each test cassette in the T reagent area, the conjugate antigens complex will be bound with the test cassette’s antibody coated on the membrane in case of a positive result. This would show in a dark red colored line in the T line region of a positive result. In case of negative result, no conjugate would bind at the test cassette’s antibody in the T line region and no line would form in the T line region of the test membrane. The C line serves as an internal qualitative control of the test system to indicate that an adequate volume of specimen has been applied and the flow occurred. Absence of C line indicates an invalid test result.
MobiLab Medical Innovatives Inc.
MSSH
Not in Commercial Distribution

  • 00860008737304 ()


  • Sexually transmitted infection (STI) testing specimen collection kit IVD, home-use
Patient-specific, partial-face 3D printed anatomic model depicting a patient’s treatment plan. Non-diagnostic. RX only
Mirrorme3d, LLC
MNMS
In Commercial Distribution

  • 00860008704184 ()


  • Custom-made organ/bone anatomy model
Patient-specific, partial face 3D printed anatomic model depicting a patient’s baseline or preoperative status. Non-diagnostic. Rx only.
Mirrorme3d, LLC
MNMB
In Commercial Distribution

  • 00860008704177 ()


  • Custom-made organ/bone anatomy model
Patient-specific, partial-face 3D printed anatomic model depicting a patient’s treatment plan. Non-diagnostic. RX only.
Mirrorme3d, LLC
MRCS
In Commercial Distribution

  • 00860008704160 ()


  • Custom-made organ/bone anatomy model
Patient-specific, partial face 3D printed anatomic model depicting a patient’s baseline or preoperative status. Non-diagnostic. Rx only.
Mirrorme3d, LLC
MRCB
In Commercial Distribution

  • 00860008704153 ()


  • Custom-made organ/bone anatomy model
Patient-specific, full-face 3D printed anatomic model depicting a patient’s treatment plan. Non-diagnostic. RX only.
Mirrorme3d, LLC
FFS
In Commercial Distribution

  • 00860008704146 ()


  • Custom-made organ/bone anatomy model
Patient-specific, full-face 3D printed anatomic model depicting a patient’s baseline or preoperative status. Non-diagnostic. Rx only.
Mirrorme3d, LLC
FFB
In Commercial Distribution

  • 00860008704139 ()


  • Custom-made organ/bone anatomy model
OxiWear Device and Charger Bundle - Medical - Package of 1
OXIWEAR, INC.
OxiV3
In Commercial Distribution

  • 00860008683236 ()
  • 10860008683233 ()
  • 20860008683230 ()
M-001-01

  • Wearable multiple physiological parameter recorder, reusable
Endovaginal Probe 3D
Halo Medical Technologies, LLC
HMT-EVG 3D
In Commercial Distribution

  • 00860008657374 ()


  • Rectal/vaginal ultrasound imaging transducer
Endovaginal Probe 2D
Halo Medical Technologies, LLC
HMT-EVG
In Commercial Distribution

  • 00860008657367 ()


  • Rectal/vaginal ultrasound imaging transducer
Midcrystal Probe 3D
Halo Medical Technologies, LLC
HMT-MCP 3D
In Commercial Distribution

  • 00860008657350 ()


  • Rectal/vaginal ultrasound imaging transducer
MidCrystal Probe 2D
Halo Medical Technologies, LLC
HMT-MCP
In Commercial Distribution

  • 00860008657343 ()


  • Rectal/vaginal ultrasound imaging transducer
Transrectal Probe 3D
Halo Medical Technologies, LLC
HMT-TRP 3D
In Commercial Distribution

  • 00860008657336 ()


  • Rectal/vaginal ultrasound imaging transducer
Transrectal Probe 2D
Halo Medical Technologies, LLC
HMT-TRP
In Commercial Distribution

  • 00860008657329 ()


  • Rectal/vaginal ultrasound imaging transducer
MI Cancer Seek is a next-generation sequencing (NGS) based in vitro diagnostic (IVD) device using total nucleic acid (TNA) isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens for the detection of single nucleotide variants (SNVs) and insertions and deletions (indels) in 228 genes, microsatellite instability (MSI) tumor mutational burden (TMB) in patients with previously diagnosed solid tumors, and copy number amplification (CNA) in one gene in patients with breast cancer. MI Cancer Seek is intended as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies listed in the approved therapeutic product labeling. Additionally, MI Cancer Seek is intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients with previously diagnosed solid malignant neoplasms. Genomic findings other than those listed as companion diagnostic indications are not prescriptive or conclusive for labeled use of any specific therapeutic product.
CARIS MPI, INC.
MCS000
In Commercial Distribution

  • 00860008613325 ()


  • Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
No Description
Sleepres, LLC
1004
In Commercial Distribution

  • 10860008554304 ()
  • 00860008554307 ()


  • Inspiratory/expiratory limb respiratory tubing, reusable
Rapid chromatographic immunoassays for the qualitative detection of LH in urine, as an aid in detection of ovulation. This test is intended for over-the-counter use.
The Bird And Be Co Inc
LHUS
In Commercial Distribution

  • 00860008449016 ()


  • Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing
No Description
XORAN TECHNOLOGIES LLC
10040
In Commercial Distribution

  • 00860008443755 ()


  • Cone beam computed tomography system, head/neck
No Description
XORAN TECHNOLOGIES LLC
10015
In Commercial Distribution

  • 00860008443731 ()


  • Cone beam computed tomography system, head/neck
TRON is a mobile, open bore, fluoroscope and cone beam computed tomography system designed for high-resolution bone window and soft tissue imaging of anatomy that fits within the imaging aperture.
XORAN TECHNOLOGIES LLC
11050
In Commercial Distribution

  • 00860008443700 ()


  • Mobile general-purpose fluoroscopic x-ray system, digital
No Description
Brazen Goods Inc.
Shortie
In Commercial Distribution

  • 00860008392121 ()
  • 00860008392176 ()


  • Oral/vaginal sex barrier, Hevea-latex
No Description
Brazen Goods Inc.
Bikini
In Commercial Distribution

  • 00860008392138 ()
  • 00860008392169 ()


  • Oral/vaginal sex barrier, Hevea-latex
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