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Radiation Shielding Panel, portal/mobile
Rampart Ic, LLC
M1128-RTV01
In Commercial Distribution
- 00860002090108 ()
- Radiation shielding panel, portable/mobile
Seven ovulation tests
Get Stix Inc.
1
In Commercial Distribution
- 00860002060415 ()
- 00850024942394 ()
- Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
The LetsGetChecked Coronavirus (COVID-19) Home Collection Kit is a direct to consumer product for testing of anterior nasal swab specimens collected at home using the LetsGetChecked Coronavirus (COVID-19) Home Collection Kit by any individuals, age 18 years and older (self-collected), 12 years and older (self-collected under adult supervision), or 2 years and older (collected with adult assistance) including individuals without symptoms or other reasons to suspect COVID-19. The LetsGetChecked Coronavirus (COVID-19) Home Collection Kit enables the at-home collection of an anterior nasal swab sample that is then transported to a laboratory designated by LetsGetChecked, Inc. for TMA testing for SARS-CoV-2 with the LetsGetChecked Coronavirus (COVID-19) Test without prescription. The LetsGetChecked Coronavirus (COVID-19) Home Collection Kit may be available direct to consumer (DTC) without a prescription at a physical retail location and online direct to consumer. Activation can only be completed by an adult. When a minor is using the kit, it is activated in a sub-account of the adult. Customers cannot create a sub-account for an infant (<2years). LetsGetChecked HCP will contact all individuals receiving positive and invalid test results. Individuals with negative test results will be notified by email, phone message and through the website portal. For purposes of this EUA, a healthcare provider includes any healthcare professional with prescribing abilities including, but not limited to, physicians, nurses, pharmacists, and laboratory directors. The healthcare provider contacting individuals with test results will have prescribing privileges for that individual, should medication be indicated for treatment.
PRIVAPATH DIAGNOSTICS LIMITED
NO14S, NO15S, NO05S
In Commercial Distribution
- 00860002028095 ()
- Oral/upper respiratory tract specimen collection kit IVD, home-use
Decorated Adhesive Bandages, assorted sizes, strips 0.75 IN x 3 IN (19 mm x 76 mm); circles 1.25 IN x 1.25 IN (31 mm x 31 mm)
Aso LLC
860001904314
Not in Commercial Distribution
- 20860001904318 ()
- 00860001904314 ()
- 60860001904316 ()
- Skin-cover adhesive strip, non-antimicrobial
Medical device for aesthetic use and pain management.
Tama Research Corp.
TA1021
In Commercial Distribution
- 00860001881561 ()
TA1021
- Multi-modality physical therapy system, professional-use
Medical device for aesthetic use and pain management.
Tama Research Corp.
TA1018
In Commercial Distribution
- 00860001881554 ()
TA1018
- Multi-modality physical therapy system, professional-use
Medical device for aesthetic use and pain management.
Tama Research Corp.
TA1015+
In Commercial Distribution
- 00860001881547 ()
TA1015+
- Multi-modality physical therapy system, professional-use
Medical device for aesthetic use and pain management.
Tama Research Corp.
TA1012
In Commercial Distribution
- 00860001881523 ()
TA1012
- Multi-modality physical therapy system, professional-use
Medical device for aesthetic use and pain management.
Tama Research Corp.
TA1017
In Commercial Distribution
- 00860001881516 ()
TA1017
- Multi-modality physical therapy system, professional-use
Medical device for aesthetic use and pain management.
Tama Research Corp.
TA1014
In Commercial Distribution
- 00860001881509 ()
TA1014
- Multi-modality physical therapy system, professional-use
This condom is made of a natural latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip; nominal length 180 mm, nominal width 52 mm, and nominal thickness 0.045mm. It is lubricated with silicone and cornstarch is used as a dressing material. This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and IS0 407. The condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted infections.
ISSAWRAP INC
Exceptionally Thin Latex Condoms
In Commercial Distribution
- 00860001852400 ()
- 00860001852417 ()
- Basic male condom, Hevea-latex
Education Unit for Movive
Medrhythms, Inc.
005EDU
In Commercial Distribution
- 00860001790832 ()
- Neuromuscular rehabilitation software
Education Unit for InTandem
Medrhythms, Inc.
001EDU
In Commercial Distribution
- 00860001790825 ()
- Neuromuscular rehabilitation software
Movive is indicated to support gait rehabilitation and motor function for people living with Parkinson's disease. Movive is intended to be used in the home for the physical rehabilitation of ambulatory adults with walking impairments from Parkinson's disease.
Medrhythms, Inc.
0050
In Commercial Distribution
- 00860001790818 ()
- Neuromuscular rehabilitation software
InTandem is indicated to improve walking and ambulation in adult chronic stroke patients. InTandem is intended to be used in the home for the physical rehabilitation of ambulatory adults with chronic stroke walking impairments.
Medrhythms, Inc.
0010
In Commercial Distribution
- 00860001790801 ()
- Neuromuscular rehabilitation software
Natalist Ovulation Test is a self-testing rapid chromatographic immunoassay for the qualitative detection of human luteinizing hormone (LH) in urine to predict the time of ovulation. There are 7pcs of 6mm midstreams in each box.
Equinox Biotech Co., Ltd.
82221
In Commercial Distribution
- 00860001730210 ()
RH-LH-B
- Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
Natalist Pregnancy Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. There are 3 6mm midstreams in one box.
Equinox Biotech Co., Ltd.
82214
In Commercial Distribution
- 00860001730203 ()
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Virtual Field VF3 is a portable virtual reality visual field device. It runs a variety of visual field patterns, including but not limited to 10-2, 24-2, and 30-2, as well as multiple strategies, from suprathreshold screenings to full threshold tests. It also includes a color vision screening exam.
Field Virtual Inc
VF3
In Commercial Distribution
- 00860001720433 ()
White
- Perimeter, automatic
- Colour discrimination tester
Virtual Field VF3 is a portable virtual reality visual field device. It runs a variety of visual field patterns, including but not limited to 10-2, 24-2, and 30-2, as well as multiple strategies, from suprathreshold screenings to full threshold tests. It also includes a color vision screening exam.
Field Virtual Inc
VF3
In Commercial Distribution
- 00860001720426 ()
Dark Gray
- Perimeter, automatic
- Colour discrimination tester
Virtual Field is a portable virtual reality visual field device. It runs a variety of visual field patterns, including but not limited to 10-2, 24-2, and 30-2, as well as multiple strategies, from suprathreshold screenings to full threshold tests. It also includes eye tracking capabilities, a color vision screening exam, and a pupillometer exam. The Virtual Field Website is used to launch exams, view patient results, and manage account information.
Field Virtual Inc
VF Software
In Commercial Distribution
- 00860001720419 ()
Release Version 2023.4.2
- Pupillometer, electrically-powered
- Perimeter, automatic
- Colour discrimination tester
- Pupillograph