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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Lexie Hearing Club (Lexie B2 Self-fitting OTC Hearing Aids, Powered by Bose Bundle)
HEARX GROUP (PTY) LTD
Lexie B2 Self-fitting OTC Hearing Aids, Powered by Bose
Not in Commercial Distribution

  • 00850022464942 ()


  • Air-conduction hearing aid, receiver-in-canal
REF: ABTDOAO17701A, FDA OTC, 1T/kit, AMP500/COC150/FYL1/MDMA500/MET500/MOP300/THC50
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 06936983177689 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
StimChoice 4000 OTC 4-channel portable device with TENS/EMS/Fitness and Sports modes
COMPASS HEALTH BRANDS CORP.
E400-6R
In Commercial Distribution

  • 80092237622052 ()
  • 00092237622056 ()
  • 30092237622057 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
InTENSity at Home OTC TENS device with 12 preset programs and 100 Intensity levels
COMPASS HEALTH BRANDS CORP.
E200-6R
In Commercial Distribution

  • 30092237619590 ()
  • 00092237619599 ()
  • 80092237619595 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
1-Midstream DoCheck Wide Tip;1 per box;hCG Pregnancy Test 25 mIU/mL OTC
WONDFO USA CO., LTD.
DW1-M-DW
In Commercial Distribution

  • 10816862024323 ()
  • 00816862024326 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
AESTHETIC - Floor Model Low Level Laser -- 12 diodes 640nm 17mW - OTC (Non-prescriptive) - IFU Reduction Circumference
ERCHONIA CORPORATION, LLC
JZB
In Commercial Distribution

  • 00858985006261 ()


  • Low-intensity laser fat liquefaction system
SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel 1 ng/ml OTC; 10 Test/Box
WONDFO USA CO., LTD.
DWFTY-OTC1-10BX
In Commercial Distribution

  • 10816862026112 ()
  • 00816862026115 ()
  • 00816862026108 ()


  • Fentanyl IVD, kit, rapid ICT, clinical
SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel 1 ng/ml OTC; 5 Test/Box
WONDFO USA CO., LTD.
DWFTY-OTC1-5BX
In Commercial Distribution

  • 10816862026099 ()
  • 00816862026092 ()
  • 00816862026085 ()


  • Fentanyl IVD, kit, rapid ICT, clinical
SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel 1 ng/ml OTC; 25 Test/Box
WONDFO USA CO., LTD.
DWFTY-OTC1-25BX
In Commercial Distribution

  • 10816862026136 ()
  • 00816862026139 ()
  • 00816862026122 ()


  • Fentanyl IVD, kit, rapid ICT, clinical
1 iFOB Fecal Occult Blood Test OTC; 1 Cassettes + 1 Collection Tube + 1 Collection Paper
WONDFO USA CO., LTD.
WFOB-OTC-1BX
In Commercial Distribution

  • 10816862025979 ()
  • 00816862025972 ()


  • Faecal occult blood IVD, kit, rapid ICT, clinical
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