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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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Waterpik Complete Care Sonic 9.0 - 00073950233033

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

Waterpik Sensonic Complete Care - 00073950330046

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

Waterpik Cordless Pearl Water Flosser and Sensonic Toothbrush - 00073950324779

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

Waterpik Complete Care Sensonic - 00073950314596

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

Waterpik Complete Care Sensonic - 00073950314572

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

Waterpik Complete Care Oscillating 9.5 - 00073950233095

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

Waterpik Complete Care Oscillating 9.5 - 00073950233071

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

Waterpik Complete Care Sonic 9.0 - 00073950233057

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

Gurunanda Ultimate Oral Care Combo - 00810051084313

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

A-dec - 10194665001254

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

A-dec - 10194665001063

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

A-dec - 10194665000967

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

Adventure Medical Kits - 00050428454442

First Aid Kit Containing class I medical devices and OTC drugs
Adventure Ready Brands
1
In Commercial Distribution

  • 00050428454442 ()


  • First aid kit, medicated

Adventure Medical Kits - 00050428442630

First Aid Kit Containing class I medical devices and OTC drugs
Adventure Ready Brands
1
In Commercial Distribution

  • 00050428442630 ()


  • First aid kit, medicated

Tens 7000 - 00092237621998

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

SAFElife™ - 00816862025958

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

SAFElife™ - 00816862025934

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

SAFElife™ - 00816862025910

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

SAFElife™ - 00816862025897

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

Novidan - 00850049194280

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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