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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OPEN-MEDIUM/991011-SWH; 10-pc blister pack of replacement ear domes for RIC used on Sontro Self-Fitting OTC Hearing Aids
Soundwave Hearing, LLC
991011-SWH
In Commercial Distribution

  • 00850016231291 ()


  • Earmould, preformed
OPEN-SMALL/991010-SWH; 10-pc blister pack of replacement ear domes for RIC used on Sontro Self-Fitting OTC Hearing Aids
Soundwave Hearing, LLC
991010-SWH
In Commercial Distribution

  • 00850016231284 ()


  • Earmould, preformed
Battery powered, home use (OTC) diode laser indicated for use in the treatment of periorbital and perioral wrinkles.
Tanda Beauty Canada, Inc
HU-FG01751
In Commercial Distribution

  • 00806248007296 ()


  • Cosmetic red-light phototherapy system, home-use
Battery powered, home use (OTC) diode laser indicated for use in the treatment of periorbital and perioral wrinkles.
Tanda Beauty Canada, Inc
HU-CO00621
In Commercial Distribution

  • 10806248006333 ()
  • 00806248006336 ()
HU-CO00621

  • Cosmetic red-light phototherapy system, home-use
Battery powered, home use (OTC) diode laser indicated for use in the treatment of periorbital and perioral wrinkles.
Tanda Beauty Canada, Inc
HU-FG00851US
In Commercial Distribution

  • 10806248005329 ()
  • 00806248005322 ()
HU-FG00851US

  • Cosmetic red-light phototherapy system, home-use
The HP Hearing PRO self-fitting air conduction hearing aid for Over-the-Counter (OTC) sale to consumers in the new OTC product classification QUH. HP Hearing PRO OTC hearing aids are intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. They are adjusted by the user to meet the user’s hearing needs. No pre-programming or hearing test is necessary.
NUHEARA LIMITED
NU320-02
In Commercial Distribution

  • 00850000562004 ()


  • Air-conduction hearing aid, in-the-ear
TULIP-ONE SIZE (12MM)/991013-SWH; 10-pc blister pack of replacement ear domes for RIC used on Sontro Self-Fitting OTC Hearing Aids
Soundwave Hearing, LLC
991013-SWH
In Commercial Distribution

  • 00850016231314 ()


  • Earmould, preformed
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
The LED Eye mask (Model: A20) is an Over-the-Counter (OTC) device intended for use in treating wrinkles within the periorbital region.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
A20
In Commercial Distribution

  • 00628176949581 ()


  • Cosmetic red-light phototherapy system, home-use
The LED Eve Mask (Model: EY-20R) is an Over-the-Counter (OTc) device intended for use in treating wrinkles within the periorbital region.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
EY-20R
In Commercial Distribution

  • 06970006971144 ()


  • Blue/red/infrared phototherapy lamp
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