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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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The LED Eye Perfector (Model: EY-36A) is an Over-the-Counter (OTC) device intended for use in treating wrinkles within the periorbital region
Shenzhen Kaiyan Medical Equipment Co,. Ltd
EY-36A
In Commercial Distribution

  • 00655729008266 ()


  • Cosmetic red-light phototherapy system, home-use
First Aid Kit containing Medical Devices Class I and Drugs OTC: Elastic Band, Biohazard Bag, Antiseptic Wipes, Facemask with shield, Nitrile Gloves.
North Safety de Mexicali, S. de R. L. de C.V.
019746-0032L
In Commercial Distribution

  • 00821812030111 ()


  • First aid kit, medicated
First aid kit refill with Smart Compliance boxes. Contains first aid supplies to help treat minor injuries and includes ingestible OTC drugs.
Acme United Corporation
91112
In Commercial Distribution

  • 00092265911122 ()
91112

  • First aid kit, medicated
STATCUP II 12 Panel OTC Test Cup, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC, 1 test per box
MICRO DISTRIBUTING, L.C
STATII-71127-0-OTC
In Commercial Distribution

  • 00816036025418 ()
STATII-71127-0-OTC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
OTC hearing aids, behind-the-ear micro design, 4 preset hearing modes, 11 volume levels, with rechargeable lithium battery, charging case and power adapter included.
Voxx Accessories Corp.
RSH062SL
In Commercial Distribution

  • 00044476157424 ()


  • Air-conduction hearing aid, behind-the-ear
OTC hearing aids, behind-the-ear micro design, 4 preset hearing modes, 11 volume levels, with rechargeable lithium battery, charging case and power adapter included.
Voxx Accessories Corp.
RSH062BG
In Commercial Distribution

  • 00044476157417 ()


  • Air-conduction hearing aid, behind-the-ear
Tens 7000 OTC Electrodes, White Cloth, Mixed 32/pk Includes (16) 2" x 2" square electrodes and (16) 2" x 4" rectangle electrodes
COMPASS HEALTH BRANDS CORP.
DT7202-ELEC204032
In Commercial Distribution

  • 00092237622162 ()
  • 30092237622163 ()
  • 80092237622168 ()
  • 01092237622161 ()


  • Transcutaneous electrical stimulation electrode, single-use
● It is a portable, battery-powered, transcutaneous electrical nerve stimulator (TENS device) that is intended for symptomatic relief of chronic intractable pain. ● OTC TENS Device.
WELL-LIFE HEALTHCARE LTD.
WL-2407
Not in Commercial Distribution

  • 04719872264071 ()


  • Physical therapy transcutaneous electrical stimulation system, line-powered
First Aid Kit containing Medical Devices Class I and Drugs OTC: Gauze Bandage, Tape Adhesive, Buffered Eye Wash, Scissor Bandage, Nitrile gloves, Burn Dressing.
North Safety de Mexicali, S. de R. L. de C.V.
019727-0014L
In Commercial Distribution

  • 00821812030289 ()


  • First aid kit, medicated
Lexie B2, Powered by Bose re-chargeable self-fitting hearing aid
HEARX GROUP (PTY) LTD
Lexie B2 Self-fitting OTC Hearing Aids Powered by Bose
In Commercial Distribution

  • 10850022464642 ()
  • 00850022464645 ()
In-Store

  • Air-conduction hearing aid, receiver-in-canal
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