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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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First Aid Kit Refill for SmartCompliance XL Business first aid kits without ingestible OTC drugs
Acme United Corporation
91113
In Commercial Distribution

  • 00092265911139 ()
91113

  • First aid kit, medicated
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
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
Dental Tool Kit, 1 Dental Scaler, 1 Mirror, 1 Dental Pick, and 1 Tongue Cleaner
WALGREEN CO.
203666
In Commercial Distribution

  • 10311917197378 ()
  • 00311917197371 ()


  • Dental mirror, reusable
  • Periodontal pick/brush, reusable
  • Tongue scraper, reusable
  • Manual dental scaler, reusable
Dental Tool Kit
Topco Associates, LLC
XES
In Commercial Distribution

  • 10036800442242 ()
  • 00036800442245 ()


  • Dental mirror, reusable
  • Manual dental scaler, reusable
  • Periodontal pick/brush, reusable
  • Tongue scraper, reusable
Dental Tool Kit
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
1T8
In Commercial Distribution

  • 00050428272695 ()


  • Dental mirror, reusable
  • Manual dental scaler, reusable
  • Periodontal pick/brush, reusable
  • Tongue scraper, reusable
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
AESTHETIC - Floor Model Low Level Laser -- 8 diodes 405nm 25mW - OTC (Non-prescriptive) - IFU Reduction Circumference/Fat
ERCHONIA CORPORATION, LLC
VZ8
In Commercial Distribution

  • 00858985006292 ()


  • Low-intensity laser fat liquefaction system
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
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
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