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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AESTHETIC - Floor Model Low Level Laser -- 6 diodes 635nm 17mW - OTC (Non-prescriptive) - IFU Reduction Circumference/Fat
ERCHONIA CORPORATION, LLC
SHR
In Commercial Distribution

  • 00858985006124 ()
SHR

  • Low-intensity laser fat liquefaction system
The DemarkQ is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.
Light Tree Ventures Europe B.V.
P19-0007
In Commercial Distribution

  • 08720299044227 ()


  • Red/blue light phototherapy unit
INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use) AMP COC MET MOR PCP THC MDMA(XTC)
ALFA SCIENTIFIC DESIGNS, INC.
03-4703OT
In Commercial Distribution

  • 10796918002065 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use) AMP BAR BUP BZD COC MET MOR MTD OXY300 PCP THC MDMA(XTC)
ALFA SCIENTIFIC DESIGNS, INC.
03-4701OT
In Commercial Distribution

  • 10796918002058 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLOSED-LARGE/991016-SWH; 10-pc blister pack of replacement ear domes for RIC used on Sontro Self-Fitting OTC Hearing Aids
Soundwave Hearing, LLC
991016-SWH
In Commercial Distribution

  • 00850016231345 ()


  • Earmould, preformed
CLOSED-MEDIUM/991015-SWH; 10-pc blister pack of replacement ear domes for RIC used on Sontro Self-Fitting OTC Hearing Aids
Soundwave Hearing, LLC
991015-SWH
In Commercial Distribution

  • 00850016231338 ()


  • Earmould, preformed
CLOSED-SMALL/991014-SWH; 10-pc blister pack of replacement ear domes for RIC used on Sontro Self-Fitting OTC Hearing Aids
Soundwave Hearing, LLC
991014-SWH
In Commercial Distribution

  • 00850016231321 ()


  • Earmould, preformed
OPEN-LARGE/991012-SWH; 10-pc blister pack of replacement ear domes for RIC used on Sontro Self-Fitting OTC Hearing Aids
Soundwave Hearing, LLC
991012-SWH
In Commercial Distribution

  • 00850016231307 ()


  • Earmould, preformed
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
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