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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Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient’s skin and the Electrical Stimulator. Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use. Adhesive electrodes are intended for use
Shenzhen Damiti Technology Co., Ltd.
AS0505-P-B
In Commercial Distribution

  • 06972929601009 ()


  • Transcutaneous electrical stimulation electrode, single-use
EMPACT 6+ Patient Hart Case Kit with Batons and Extra Hemostatic Dressing. Tactical & Medical Trauma Kit. Tactical side Has Batons, TAC-Wedge, TAC-Keys and other Tactical components that can be used in an active shooter RUN, HIDE, FIGHT situation. Medical side has OTC Bleeding Control Kits featuring extra Hemostatic Dressing and other Trauma First-Aid equipment .
Pro1tek
B283E6HCXOC0
In Commercial Distribution

  • B283E6HCXOC0 ()


  • First aid kit, medicated
All-Purpose First Aid Kit: 200 pieces containing medical devices and OTC drugs: cotton tipped applicator, nitrile gloves, wooden finger splint, cold pack, metal tweezers, scissors, antiseptic wipes, acetaminophen, aspirin, ibuprofen, alcohol prep pad, sting relief wipe, antibiotic ointment, burn gel, adhesive bandages, gauze pads, non-stick pad, gauze pad, paper tape, rolled gauze, surgical pad.
Aso LLC
017276234176
Not in Commercial Distribution

  • 10017276234173 ()
  • 00017276234176 ()
017276234176

  • First aid kit, medicated
Silver collagen wound gel (42 g tube) is a medical hydrolysate of collagen with silver oxide. OTC for minor burns, superficial cuts, lacerations, abrasions, irritations of the skin. RX for partial and full thickness wounds. Store at controlled room temperature. Silver oxide controls the growth of microbes that are absorbed into the wound gel. https://dermarite.com/product/silvakollagen-gel/
The Hymed Group Corporation
00500
In Commercial Distribution

  • 00860008336217 ()
  • 00860008336200 ()


  • Collagen wound matrix dressing
Silver collagen wound gel (42 g tube) is a medical hydrolysate of collagen with silver oxide. OTC for minor burns, superficial cuts, lacerations, abrasions, irritations of the skin. RX for partial and full thickness wounds. Store at controlled room temperature. Silver oxide controls the growth of microbes that are absorbed into the wound gel. https://dermarite.com/product/silvakollagen-gel/
DERMARITE INDUSTRIES LLC
00500
In Commercial Distribution

  • 01714196500150 ()
  • 00714196500151 ()
00500

  • Collagen wound matrix dressing
First Aid Kit containing Medical Devices class I and Drugs OTC: Neomycin Antibiotic, Triangular Bandage, Rescue Blanket, Gauze Compress, Hydrocortisone, Plastic Tweezer, Adhesive Bandage, Antiseptic, Burn Relief, Adhesive Tape, Gauze Clean-wrap Bandage, Gauze Pads, CPR Filter Shield, PVP Pre pads, Buffered Eye Wash, Scissor Bandage, Nitrile gloves, Cold Pack, Eye Pads, Woven Fingertip Bandage, Woven Knuckle Bandage.
North Safety de Mexicali, S. de R. L. de C.V.
018504-4222
In Commercial Distribution

  • 00821812024523 ()


  • First aid kit, medicated
The Comfy Curve Massage Pro device is an electrically powered, vibrating therapeutic massager. The device consists of a memory foam pillow with a small internal motor, powered by (2) AA batteries (not included), that vibrates the entire pillow. The Comfy Curve Massage Pro is an OTC device that is intended to be used on the body for relief of minor aches and pains.
Spark Innovators Corporation
CCPMP-MC3
In Commercial Distribution

  • 20850018026165 ()
  • 00850018026161 ()

  • Width: 18 Inch


  • Hand-held electric massager
PainKARE is an OTC medical device intended to temporarily relieve pain due to strain from exercise or normal household work or activities via electro-therapy. The Device consists two Stimulator pads connected by a USB cable for Electrotherapy.'' PainKARE’s Stimulator pads operate in a programmable micro-current mode and deliver Biphasic waveforms which in turn provide electrical stimulation to the body that aids in relieving pain.
TRIOWAVE TECHNOLOGIES
PK001
In Commercial Distribution

  • 00866946000302 ()


  • Analgesic transcutaneous electrical nerve stimulation system
Powered heating pad. An assembly of mains electricity (AC-powered) devices designed for the transcutaneous application of heat to a localized body site (e.g., joint, limb) to relieve musculoskeletal pain. It consists of an electric heating pad typically made of synthetic fabric materials, and a hand-held control unit used to regulate and monitor the heat. It is normally available [non-prescription] over-the-counter (OTC) for use in the home.
Hayswell
HP-3000
In Commercial Distribution

  • 00860036001101 ()


  • Electric pad localized-body heating system
Professional + All Purpose First Aid Kit: 351 pieces containing medical devices and OTC drugs: burn dressing, cold pack, adhesive bandages, butterfly closure, gauze pads, eye pad, trauma pad, CPR breathing barrier, rolled gauze, cotton swabs, paper tape, finger splint, triangular sling, nitrile gloves, scissors, tweezers, alcohol prep pad, antiseptic wipes, hand sanitizer, eye wash, burn gel, antibiotic ointment, acetaminophen, aspirin, ibuprofen and sting relief wipe.
Aso LLC
B07CGFT1FF
Not in Commercial Distribution

  • 00017276233599 ()
  • 10017276233596 ()

  • 13.0 x 11.75 x 4.25 in
B07CGFT1FF

  • First aid kit, medicated
Menstrual Disc, medical grade silicone non-latex, soft reusable disc placed by the user into the vagina, help in place by the pelvic muscles, and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons. It is available OTC (Over the Counter). It is removed from the vagina by pulling on the pull tab. This is a reusable device for a single user.
Diva International Inc
1
In Commercial Distribution

  • 00841445001678 ()


  • Menstrual cup, non-latex, reusable
Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons.It is available OTC (Over the counter). It is removed from the vagina by releasing the suction and pulling on the protruding stem. This is a reusable device for a single user.
Lunapads International Products Ltd
Model A
In Commercial Distribution

  • 00625564000381 ()


  • Menstrual cup, non-latex, reusable
Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons.It is available OTC (Over the counter). It is removed from the vagina by releasing the suction and pulling on the protruding stem. This is a reusable device for a single user.
Lunapads International Products Ltd
Model B
In Commercial Distribution

  • 00625564000398 ()


  • Menstrual cup, non-latex, reusable
Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons.It is available OTC (Over the counter). It is removed from the vagina by releasing the suction and pulling on the protruding stem. This is a reusable device for a single user.
Diva International Inc
Model Teen Size
Not in Commercial Distribution

  • 00857538000244 ()
DV00T

  • Menstrual cup, non-latex, reusable
Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons.It is available OTC (Over the counter). It is removed from the vagina by releasing the suction and pulling on the protruding stem. This is a reusable device for a single user.
Diva International Inc
Model 0
In Commercial Distribution

  • 00857538000237 ()
DV000

  • Menstrual cup, non-latex, reusable
Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons.It is available OTC (Over the counter). It is removed from the vagina by releasing the suction and pulling on the protruding stem. This is a reusable device for a single user.
Diva International Inc
MT Cup Model B
Not in Commercial Distribution

  • 00857538000169 ()
MT002

  • Menstrual cup, non-latex, reusable
Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons.It is available OTC (Over the counter). It is removed from the vagina by releasing the suction and pulling on the protruding stem. This is a reusable device for a single user.
Diva International Inc
MT Cup Model A
Not in Commercial Distribution

  • 00857538000152 ()
MT001

  • Menstrual cup, non-latex, reusable
Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons.It is available OTC (Over the counter). It is removed from the vagina by releasing the suction and pulling on the protruding stem. This is a reusable device for a single user.
Diva International Inc
Model B PL
Not in Commercial Distribution

  • 00857538000145 ()
722537

  • Menstrual cup, non-latex, reusable
Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons.It is available OTC (Over the counter). It is removed from the vagina by releasing the suction and pulling on the protruding stem. This is a reusable device for a single user.
Diva International Inc
Model A PL
Not in Commercial Distribution

  • 00857538000138 ()
634864

  • Menstrual cup, non-latex, reusable
Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons.It is available OTC (Over the counter). It is removed from the vagina by releasing the suction and pulling on the protruding stem. This is a reusable device for a single user.
Diva International Inc
Model 2
In Commercial Distribution

  • 10857538000043 ()
  • 00857538000022 ()
  • 10857538000272 ()
  • 10857538000081 ()
DV002

  • Menstrual cup, non-latex, reusable
Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons.It is available OTC (Over the counter). It is removed from the vagina by releasing the suction and pulling on the protruding stem. This is a reusable device for a single user.
Diva International Inc
Model 1
In Commercial Distribution

  • 10857538000258 ()
  • 00857538000015 ()
  • 10857538000074 ()
  • 10857538000036 ()
DV001

  • Menstrual cup, non-latex, reusable
Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons.It is available OTC (Over the counter). It is removed from the vagina by releasing the suction and pulling on the protruding stem. This is a reusable device for a single user.
DOT INTERNATIONAL L3C
1
In Commercial Distribution

  • 00860499001908 ()


  • Menstrual cup, non-latex, reusable
A convenient collection of equipment and materials typically used in an emergency by a layperson to repair a damaged denture. It is available [non-prescription] over-the-counter (OTC) and enables the permanent repair of denture cracks and breaks without professional assistance. It typically consists of dental adhesive materials (e.g., a resin monomer system of powder and liquid glue) and mixing and application utensils. After application, this device cannot be reused.
PERMA LABORATORIES LLC
pk6
In Commercial Distribution

  • 00852305002117 ()


  • Denture repair kit, home-use
The NIRA PRO+ is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA PRO+ 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 USB C connector interface that provides battery charging. The NIRA PRO+ is used for treatment of periorbital wrinkles.
Nira Innovations Incorporated
174-000
In Commercial Distribution

  • 00850020752454 ()


  • Dermatological laser beam guiding handpiece
The NIRA Precision Laser is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA Laser consists of a hand piece 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 USB C connector interface that provides battery charging. The NIRA Laser is used for treatment of periorbital wrinkles.
Nira Innovations Incorporated
117-000
In Commercial Distribution

  • 00850020752126 ()


  • Dermatological laser beam guiding handpiece
The NIRA PRO is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA PRO 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 USB C connector interface that provides battery charging. The NIRA PRO is used for treatment of periorbital wrinkles.
Nira Innovations Incorporated
151-000
In Commercial Distribution

  • 00850020752119 ()


  • Dermatological laser beam guiding handpiece
Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons.It is available OTC (Over the counter). It is removed from the vagina by releasing the suction and pulling on the protruding stem. This is a reusable device for a single user.
Diva International Inc
Model B PL
In Commercial Distribution

  • 00050428645888 ()
634864

  • Menstrual cup, non-latex, reusable
Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons.It is available OTC (Over the counter). It is removed from the vagina by releasing the suction and pulling on the protruding stem. This is a reusable device for a single user.
Diva International Inc
Model A PL
In Commercial Distribution

  • 00050428645598 ()
722537

  • Menstrual cup, non-latex, reusable
Reusable Menstrual Cup Menstrual Cup Model B. Medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons. It is available OTC (Over the counter). It is removed from the vagina by releasing the suction and pulling on the protruding stem. This is a reusable device for a single user.
WALGREEN CO.
864133
In Commercial Distribution

  • 00311917057446 ()
  • 10311917057443 ()


  • Menstrual cup, non-latex, reusable
Reusable Menstrual Cup, Model A. Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons. It is available OTC (Over the counter). It is removed from the vagina by releasing the suction and pulling on the protruding stem. This is a reusable device for a single user.
WALGREEN CO.
864224
In Commercial Distribution

  • 00311917057415 ()
  • 10311917057412 ()


  • Menstrual cup, non-latex, reusable
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