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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Water flosser and sonic toothbrush, gray
WATER PIK, INC.
CC-04W027-1
Not in Commercial Distribution

  • 00073950314596 ()
CC-04W027-1/TCC-030

  • Oral lavage system
  • Basic electric toothbrush
Water flosser and sonic toothbrush, white
WATER PIK, INC.
CC-04W020-1
Not in Commercial Distribution

  • 00073950314572 ()
CC-04W020-1/TCC-030

  • Oral lavage system
  • Basic electric toothbrush
Water flosser and oscillating toothbrush, black
WATER PIK, INC.
CC-02CD012-2
Not in Commercial Distribution

  • 00073950233095 ()
CC-02CD012-2

  • Oral lavage system
  • Basic electric toothbrush
Water flosser and oscillating toothbrush, white
WATER PIK, INC.
CC-02CD010-1
Not in Commercial Distribution

  • 00073950233071 ()
CC-02CD010-1

  • Oral lavage system
  • Basic electric toothbrush
Water flosser and sonic toothbrush, black
WATER PIK, INC.
CC-01CD012-2
Not in Commercial Distribution

  • 00073950233057 ()
CC-01CD012-2

  • Oral lavage system
  • Basic electric toothbrush
Water flosser and sonic toothbrush, white
WATER PIK, INC.
CC-01CD010-1
Not in Commercial Distribution

  • 00073950233033 ()
CC-01CD010-1

  • Oral lavage system
  • Basic electric toothbrush
Portable Water Flosser & Electric Toothbrush Kit with Charging Stand, Power Adapter & Replaceable Brush Heads
Gurunanda, LLC
H100/H6PLUS
In Commercial Distribution

  • 00810051084313 ()


  • Oral lavage system
  • Basic electric toothbrush
Go Hearing, Go Ultra BTE OTC hearing aid, Grey.
HEARX GROUP (PTY) LTD
Go Ultra
In Commercial Distribution

  • 00850022464959 ()


  • Air-conduction hearing aid, behind-the-ear
Fentanyl Urine Test Cassette, 1T*6,FDA, OTC,1ng
Hangzhou AllTest Biotech Co., Ltd.
DFY-A102H
In Commercial Distribution

  • 06936983144650 ()
  • 06936983143950 ()


  • Fentanyl IVD, kit, rapid ICT, clinical
Electric Motor Kit,Nano,Control Module,68 IN,OTC
A-DEC, INC.
54.0727.00
In Commercial Distribution

  • 10194665005467 ()
54.0727.00

  • Remotely-driven surgical/dental system drive cable
Syringe ASST,Mini,TRAD,Non-QD,12 FT,OTC,China
A-DEC, INC.
23.1376.02
In Commercial Distribution

  • 10194665002275 ()
23.1376.02

  • Dental delivery system irrigation handpiece
Syringe ASSY,Mini,TRAD,Non-QD,12 FT,OTC,INTL
A-DEC, INC.
23.1376.01
In Commercial Distribution

  • 10194665002268 ()
23.1376.01

  • Dental delivery system irrigation handpiece
Syringe ASSY Mini,TRAD,Non-QD,7 FT,OTC,INTL
A-DEC, INC.
23.1375.01
In Commercial Distribution

  • 10194665002237 ()
23.1375.01

  • Dental delivery system irrigation handpiece
Tip,HVE,90 Degree,Square Ends,Passivated SST,OTC
A-DEC, INC.
10.0015.00
In Commercial Distribution

  • 10194665004583 ()
10.0015.00

  • Dental suction system cannula, single-use
NLZ,Tubing ASSY/Electric Motor Kit,68 IN,OTC
A-DEC, INC.
54.0726.01
In Commercial Distribution

  • 10194665001261 ()
54.0726.01

  • Dental surgical power tool motor, electric
NLZ,Tubing ASSY/Electric Motor Kit,82 IN,OTC
A-DEC, INC.
54.0606.01
In Commercial Distribution

  • 10194665001070 ()
54.0606.01

  • Dental surgical power tool motor, electric
NLZ,Tubing ASSY/Electric Motor Kit,63 IN, OTC
A-DEC, INC.
54.0605.01
In Commercial Distribution

  • 10194665001056 ()
54.0605.01

  • Dental surgical power tool motor, electric
Electric Motor Kit,Nano,Control Module,82 IN,OTC
A-DEC, INC.
54.0447.00
In Commercial Distribution

  • 10194665000820 ()
54.0477.00

  • Dental surgical power tool motor, electric
Electric Motor Kit,Nano,Control Module,61 IN,OTC
A-DEC, INC.
54.0446.00
In Commercial Distribution

  • 10194665000608 ()
54.0446.00

  • Dental surgical power tool motor, electric
Mach II Pro Wireless OTC Hearing Aids - Graphite Pair
Novidan, Inc.
99-0016-03
In Commercial Distribution

  • 00850049194334 ()


  • Air-conduction hearing aid, receiver-in-canal
Mach II Pro Wireless OTC Hearing Aids - Beige Pair
Novidan, Inc.
99-0016-02
In Commercial Distribution

  • 00850049194327 ()


  • Air-conduction hearing aid, receiver-in-canal
Mach II Pro Wireless OTC Hearing Aids - Glacier Pair
Novidan, Inc.
99-0016-01
In Commercial Distribution

  • 00850049194310 ()


  • Air-conduction hearing aid, receiver-in-canal
NoviOne RIC Wireless Rechargeable OTC Hearing Aids - Graphite Pair
Novidan, Inc.
99-0010-03
In Commercial Distribution

  • 00850049194303 ()


  • Air-conduction hearing aid, receiver-in-canal
NoviOne RIC Wireless Rechargeable OTC Hearing Aids - Beige Pair
Novidan, Inc.
99-0010-02
In Commercial Distribution

  • 00850049194297 ()


  • Air-conduction hearing aid, receiver-in-canal
Mach I Pro OTC RIC Hearing Aids, Pair - Slate
Novidan, Inc.
99-0006-07
In Commercial Distribution

  • 00850049194174 ()


  • Air-conduction hearing aid, receiver-in-canal
Mach I Pro OTC RIC Hearing Aids, Pair - Beige
Novidan, Inc.
99-0006-06
In Commercial Distribution

  • 00850049194167 ()


  • Air-conduction hearing aid, receiver-in-canal
Intense Pulse Light OTC hair removal device spare part
SPECTRUM BRANDS, INC.
SP7SB
In Commercial Distribution

  • 10074590547891 ()
  • 00074590547894 ()


  • Intense pulsed light skin surface treatment system
Intense Pulse Light OTC hair removal device spare part
SPECTRUM BRANDS, INC.
SP2000HR
In Commercial Distribution

  • 10074590542926 ()
  • 00074590542929 ()


  • Intense pulsed light skin surface treatment system
Over-The-Counter (OTC) Transcutaneous Electrical Nerve Stimulator (TENS) - Back & Hip
CHATTEM, INC.
SmartRelief 1.0 - Back/Hip Kit
In Commercial Distribution

  • 00041167080450 ()


  • Transcutaneous electrical stimulation electrode, single-use
REPLACEMENT ELECTRODE KIT, OTC INTENSITY AT HOME ELECTRODES, 8CT
COMPASS HEALTH BRANDS CORP.
E201-6R
In Commercial Distribution

  • 00092237619605 ()


  • Transcutaneous electrical stimulation electrode, single-use
1-Cassette; FTY Fentanyl 1 ng/ml OTC; 5 Tests/Kitbox
WONDFO USA CO., LTD.
WDFT-201-OTC1-5BX
In Commercial Distribution

  • 10816862024996 ()
  • 00816862024999 ()
  • 00816862024982 ()


  • Fentanyl IVD, kit, rapid ICT, clinical
1-Cassette; FTY Fentanyl 1 ng/ml OTC; 10 Tests/Kitbox
WONDFO USA CO., LTD.
WDFT-201-OTC1-10BX
In Commercial Distribution

  • 10816862024972 ()
  • 00816862024975 ()
  • 00816862024968 ()


  • Fentanyl IVD, kit, rapid ICT, clinical
1-Cassette; FTY Fentanyl 1 ng/ml OTC; 25 Tests/Kitbox
WONDFO USA CO., LTD.
WDFT-201-OTC1-25BX
In Commercial Distribution

  • 10816862024958 ()
  • 00816862024951 ()
  • 00816862024944 ()


  • Fentanyl IVD, kit, rapid ICT, clinical
1-Cassette; FTY Fentanyl 1 ng/ml OTC; 1 Test/Kitbox
WONDFO USA CO., LTD.
WDFT-201-OTC1-1BX
In Commercial Distribution

  • 10816862025870 ()
  • 00816862025873 ()


  • Fentanyl IVD, kit, rapid ICT, clinical
LEFT-LARGE/991009-SWH; replacement RIC for Sontro Self-Fitting OTC Hearing Aids
Soundwave Hearing, LLC
991009-SWH
In Commercial Distribution

  • 00850016231277 ()


  • Air-conduction hearing aid acoustic tube
LEFT-SMALL/991007-SWH; replacement RIC for Sontro Self-Fitting OTC Hearing Aids
Soundwave Hearing, LLC
991007-SWH
In Commercial Distribution

  • 00850016231253 ()


  • Air-conduction hearing aid acoustic tube
RIGHT-MEDIUM/991005-SWH; replacement RIC for Sontro Self-Fitting OTC Hearing Aids
Soundwave Hearing, LLC
991005-SWH
In Commercial Distribution

  • 00850016231239 ()


  • Air-conduction hearing aid acoustic tube
LEFT-MEDIUM/991008-SWH; replacement RIC for Sontro Self-Fitting OTC Hearing Aids
Soundwave Hearing, LLC
991008-SWH
In Commercial Distribution

  • 00850016231260 ()


  • Air-conduction hearing aid acoustic tube
RIGHT-LARGE/991006-SWH; replacement RIC for Sontro Self-Fitting OTC Hearing Aids
Soundwave Hearing, LLC
991006-SWH
In Commercial Distribution

  • 00850016231246 ()


  • Air-conduction hearing aid acoustic tube
RIGHT-SMALL/991004-SWH; replacement RIC for Sontro Self-Fitting OTC Hearing Aids
Soundwave Hearing, LLC
991004-SWH
In Commercial Distribution

  • 00850016231222 ()


  • Air-conduction hearing aid acoustic tube
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