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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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A device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the base or tissue-contacting surface of a denture for improved fitting. It is available [non-prescription] over-the-counter (OTC) and will enable the user to make a permanent adjustment without professional assistance. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused.
PERMA LABORATORIES LLC
2ps
In Commercial Distribution

  • 00852305002018 ()


  • Denture reliner, soft, home-use
Refill For SmartCompliance Cabinet With OTC Medications - Contains: Alcohol Pad, 20 ct; Antibiotic Ointment, 10 ct; Antiseptic Wipes, 10 ct; Aspirin Tablets, 20 ct; Butterfly Wound Closure, 10 ct; Extra-Strength Non-Aspirin Tablets, 20 ct; Fabric Bandage, 1" x 3", 50 ct; Fingertip Fabric Bandage, 10 ct; First Aid Tape, 1/2" x 10 yd; First Aid/Burn Cream, 10 ct; Gauze Roll Bandage, 3”; Ibuprofen Tablets, 40 ct; Knuckle Fabric Bandage, 10 ct; Plastic Bandage, 3/4" x 3", 25 ct.
Acme United Corporation
700002
In Commercial Distribution

  • 00092265700023 ()
700002

  • First aid kit, medicated
The NIRA Laser is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA Laser consists of a hand piece, wall-plug battery charger, and 1.5 foot USB cable. The hand piece fits in the hand and the laser light comes out of the tip. There is a single micro-USB connector interface that provides two functions: battery charging and USB communication (for charging, factory programming setup and factory diagnosis of returned devices). The NIRA Laser is used for treatment of periorbital wrinkles.
Nira Innovations Incorporated
104-000
Not in Commercial Distribution

  • 00860296000142 ()


  • Dermatological laser beam guiding handpiece
A cup-like receptacle placed by the user into the vagina to collect blood and cellular debris discharges during menstruation and discharges outside of the monthly menses. It is a small, soft device made of a biocompatible synthetic material (e.g., silicone elastomer) and is normally available [non-prescription] over-the-counter (OTC). It is typically removed from the vagina by pulling on a protruding stem; depending upon design, it may or may not touch the cervix. The device can function as an alternative to tampons. This is a reusable device.
MIEUX LLC
1
Not in Commercial Distribution

  • 00868609000216 ()


  • Menstrual cup/disc, non-latex, reusable
ONE-CARE test strips are intended for use with ONE-CARE glucose meters for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). ONE-CARE system can be used at home (over the counter OTC) by persons with diabetes. Test strips require small blood samples size of 0.5ul to provide accurate and fast results within 5 seconds. The system is based on auto-coding technology and no programming is needed when using new batch of test strips.
MediVena, LLC
AC500
In Commercial Distribution

  • 00810008210512 ()
  • 00810008210369 ()
  • 00810008210529 ()
4007

  • Glucose monitoring system IVD, home-use
The EASY MAX Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. The EASY MAX Glucose Test Strips must be used with the EASY MAX Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
EPS BIO TECHNOLOGY CORP.
EASY MAX
In Commercial Distribution

  • 10885017000277 ()
  • 00885017000270 ()


  • Glucose IVD, kit, enzyme spectrophotometry, rapid
YE8800AR is a rechargeable lithium battery-powered, automatic, noninvasive, wrist-worn blood pressure measuring system intended for over-the-counter (OTC) use. YE8800AR is designed for wrist circumference ranging from 13.5 cm to 19.5 cm. The systolic and diastolic blood pressures are measured using the oscillometric method, where the cuff is inflated with an air pump and deflates via an exhaust valve. During inflation, the cuff pressure is monitored, and pulse waveform data is extracted. The extracted pulse waveform data is then further analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure.
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
YE8800AR
In Commercial Distribution

  • 06933257921634 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
YE8800CR is a rechargeable lithium battery-powered, automatic, noninvasive, wrist-worn blood pressure measuring system intended for over-the-counter (OTC) use. YE8800CR is designed for wrist circumference ranging from 13.5 cm to 19.5 cm. The systolic and diastolic blood pressures are measured using the oscillometric method, where the cuff is inflated with an air pump and deflates via an exhaust valve. During inflation, the cuff pressure is monitored, and pulse waveform data is extracted. The extracted pulse waveform data is then further analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure.
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
YE8800CR
In Commercial Distribution

  • 06933257921610 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
VOXAPOD menstrual cup small is a uniquely designed device that collects menstrual flow rather than absorbing it. It is a cup-like receptacle placed by the user into the vagina to collect blood and cellular debris discharges during menstruation and discharges outside of the monthly menses. It is a small, soft device made of a biocompatible synthetic material (e.g., silicone elastomer) and is normally available [non-prescription] over-the-counter (OTC). It is typically removed from the vagina by breaking the suction seal and pulling on the stem and/or base. The device can function as an alternative to tampons. This is a reusable device.
Voxa Pod, Inc.
VP-Cup-Sm-C
In Commercial Distribution

  • 00860000762335 ()


  • Menstrual cup/disc, non-latex, reusable
REVIAN RED is a non-invasive, hands-free device indicated to treat androgenetic alopecia in both men and women. It is operated via a mobile application to promote hair growth using Modulated Light Therapy (MLT) for a recommended 10-minute daily treatment. REVIAN RED is a system comprised of a wearable soft textile Cap using driver electronics,a rechargeable battery, and integrated light emitting diode (LED) flexible printed circuit board. REVIAN RED is designed as an over-the-counter (OTC) home-based device to treat the entire scalp area of the user and is controlled via a wireless Bluetooth connection to a mobile application operating on a wireless device.
Revian, Inc.
101
In Commercial Distribution

  • 00862712000309 ()

  • Width: 20 Centimeter
  • Weight: 155 Gram
  • Length: 22.86 Centimeter
  • Height: 15.87 Centimeter
10001

  • Hair growth laser device
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