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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Sentibo OTC BTE Wireless Hearing Aid, Left, Beige
INTRICON CORPORATION
L155i
In Commercial Distribution

  • 00858177007564 ()
93336-010

  • Air-conduction hearing aid, behind-the-ear
It is hair growing system for OTC use
Xuzhou Kernel Medical Equipment Co., Ltd.
KN-8000C
In Commercial Distribution

  • 06928798600360 ()


  • Hair growth laser device
It is hair growing system for OTC use
Xuzhou Kernel Medical Equipment Co., Ltd.
KN-8000E
In Commercial Distribution

  • 06928798600346 ()


  • Hair growth laser device
It is hair growing system for OTC use
Xuzhou Kernel Medical Equipment Co., Ltd.
KN-8000D
In Commercial Distribution

  • 06928798600339 ()


  • Hair growth laser device
Fentanyl Urine Test Cassette, 1T,FDA, OTC,1ng
Hangzhou AllTest Biotech Co., Ltd.
DFY-A102H
In Commercial Distribution

  • 06936983143950 ()


  • Fentanyl IVD, kit, rapid ICT, clinical
Kit, Newtron CAN,Ctrl Module, Long Tubing, OTC
A-DEC, INC.
No Version or Model Number
In Commercial Distribution

  • 10194665008345 ()
54.1043.00

  • Ultrasonic dental scaling/debridement system handpiece
Kit, Newtron CAN,Ctrl Module, Short Tubing, OTC
A-DEC, INC.
No Version or Model Number
In Commercial Distribution

  • 10194665008321 ()
54.1042.00

  • Ultrasonic dental scaling/debridement system handpiece
Pro Wireless Rechargeable OTC Hearing Aids - Graphite Pair
Novidan, Inc.
99-0017-03
In Commercial Distribution

  • 00850049194365 ()


  • Air-conduction hearing aid, receiver-in-canal
Pro Wireless Rechargeable OTC Hearing Aids - Beige Pair
Novidan, Inc.
99-0017-02
In Commercial Distribution

  • 00850049194358 ()


  • Air-conduction hearing aid, receiver-in-canal
Pro Wireless Rechargeable OTC Hearing Aids - Glacier Pair
Novidan, Inc.
99-0017-01
In Commercial Distribution

  • 00850049194341 ()


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