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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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-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
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
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
Over-The-Counter (OTC) Transcutaneous Electrical Nerve Stimulator (TENS) - Knee and Shoulder
CHATTEM, INC.
SmartRelief 1.0 - Knee/Shoulder Kit
In Commercial Distribution

  • 00041167080474 ()


  • Transcutaneous electrical stimulation electrode, single-use
Self-Fit OTC Hearing Aid Pair, wireless, rechargeable, cool gray color
Novidan, Inc.
EH-Z2000-H
In Commercial Distribution

  • 00046838505065 ()
  • 10046838505062 ()


  • Air-conduction hearing aid, receiver-in-canal
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
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 sonic toothbrush, white
WATER PIK, INC.
CC-01CD010-1
Not in Commercial Distribution

  • 00073950233033 ()
CC-01CD010-1

  • Oral lavage system
  • Basic electric toothbrush
Water flosser and sonic toothbrush, white
WATER PIK, INC.
CC-04CD010-1
In Commercial Distribution

  • 00073950330046 ()
CC-04CD010-1

  • Oral lavage system
  • Basic electric toothbrush
Rechargeable water flosser and sonic toothbrush, white
WATER PIK, INC.
STW-03W020/WF-13W030
In Commercial Distribution

  • 00073950324779 ()
STW-03W020/WF-13W030

  • 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
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
NLZ BA,Control Module/Tubing ASSY/Motor Kit,68 IN,OTC
A-DEC, INC.
54.0726.00
In Commercial Distribution

  • 10194665001254 ()
54.0726.00

  • Dental surgical power tool motor, electric
NLZ BA,Control Module/Tubing ASSY/Motor Kit,82 IN,OTC
A-DEC, INC.
54.0606.00
In Commercial Distribution

  • 10194665001063 ()
54.0606.00

  • Dental surgical power tool motor, electric
NLZ BA,Control Module/Tubing ASSY/Motor Kit,63 IN, OTC
A-DEC, INC.
54.0605.00
In Commercial Distribution

  • 10194665000967 ()
54.0605.00

  • Dental surgical power tool motor, electric
Tens 7000 OTC Electrodes, White Cloth, 2" x 4", 16/PK
COMPASS HEALTH BRANDS CORP.
DT7202-ELEC2416
In Commercial Distribution

  • 30092237621999 ()
  • 00092237621998 ()
  • 80092237621994 ()
  • 01092237621997 ()


  • Transcutaneous electrical stimulation electrode, single-use
First Aid Kit Containing class I medical devices and OTC drugs
Adventure Ready Brands
1
In Commercial Distribution

  • 00050428454442 ()


  • First aid kit, medicated
First Aid Kit Containing class I medical devices and OTC drugs
Adventure Ready Brands
1
In Commercial Distribution

  • 00050428442630 ()


  • First aid kit, medicated
1-Panel Card; FTY Fentanyl 1 ng/ml OTC; 1 Test/Kitbox
WONDFO USA CO., LTD.
WFTY-OTC1-1BX
In Commercial Distribution

  • 10816862025955 ()
  • 00816862025958 ()


  • Fentanyl IVD, kit, rapid ICT, clinical
1-Panel Card; FTY Fentanyl 1 ng/ml OTC; 5 Tests/Kitbox
WONDFO USA CO., LTD.
WFTY-OTC1-5BX
In Commercial Distribution

  • 10816862025931 ()
  • 00816862025934 ()
  • 00816862027488 ()


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

  • 10816862025917 ()
  • 00816862025910 ()
  • 00816862025903 ()


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

  • 10816862025894 ()
  • 00816862025897 ()
  • 00816862025880 ()


  • Fentanyl IVD, kit, rapid ICT, clinical
NoviOne RIC W R, Wireless Rechargeable OTC Hearing Aid Pair, Glacier color
Novidan, Inc.
99-0010-01
In Commercial Distribution

  • 00850049194280 ()


  • Air-conduction hearing aid, receiver-in-canal
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