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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NoviOne RIC Rechargeable OTC Hearing Aids - Glacier Pair
Novidan, Inc.
99-0010-04
In Commercial Distribution

  • 00850049194372 ()


  • Air-conduction hearing aid, receiver-in-canal
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
Mach I OTC BTE Hearing Aids, Pair - Charcoal
Novidan, Inc.
99-0005-21
In Commercial Distribution

  • 00850049194150 ()


  • Air-conduction hearing aid, behind-the-ear
Mach I OTC BTE Hearing Aids, Pair - Slate
Novidan, Inc.
99-0005-20
In Commercial Distribution

  • 00850049194143 ()


  • Air-conduction hearing aid, behind-the-ear
Mach I OTC BTE Hearing Aids, Pair - Beige
Novidan, Inc.
99-0005-19
In Commercial Distribution

  • 00850049194136 ()


  • Air-conduction hearing aid, behind-the-ear
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
Kit,Tubing ASSY,63 IN,A-dec 501,OTC
A-DEC, INC.
54.0796.01
In Commercial Distribution

  • 10194665005474 ()
54.0796.01

  • Remotely-driven surgical/dental system drive cable
Electric LS Package,E20 L,Expert Matic,OTC
A-DEC, INC.
54.0883.00
In Commercial Distribution

  • 10194665004545 ()
54.0883.00

  • Pneumatic dental power tool system handpiece tip, reusable
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
Sentibo OTC BTE Wireless Hearing Aid, Right, Beige
INTRICON CORPORATION
L155i
In Commercial Distribution

  • 00858177007571 ()
93336-011

  • Air-conduction hearing aid, behind-the-ear
Sentibo OTC BTE Wireless Hearing Aid, Left, Beige
INTRICON CORPORATION
L155i
In Commercial Distribution

  • 00858177007564 ()
93336-010

  • Air-conduction hearing aid, behind-the-ear
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
Amazon 10 pack of OTC 2 x 2
COMPASS HEALTH BRANDS CORP.
E1P2020BC2-TT-AMZN
In Commercial Distribution

  • 80092237616181 ()
  • 30092237616186 ()
  • 00092237616185 ()
  • 01092237616184 ()


  • Transcutaneous electrical stimulation electrode, single-use
HORMONElife™ PdG Urine Test Strip OTC 6PK
WONDFO USA CO., LTD.
W199-S-6BX
In Commercial Distribution

  • 10816862027263 ()
  • 00816862027266 ()
  • 00816862027259 ()


  • Multiple female fertility marker IVD, kit, rapid ICT, clinical
Hydrocolloid Blister Cushions, assorted cushions, 0.66 in. x 2.32 in. (17mm x 59mm); 1.33 in. x 2.12in. (34mm x 54mm); 1.65 IN x 2.67 IN (42 mm x 68 mm)
Ahold U.S.A., Inc.
041520104854
In Commercial Distribution

  • 10041520104851 ()
  • 00041520104854 ()
  • 60041520104856 ()


  • Exudate-absorbent dressing, hydrophilic-gel, non-sterile
  • Corn/callus dressing, single-use
One 3.38 FL OZ (100 mL) bottle with one lice comb.
MENTHOLATUM COMPANY, THE
1123
In Commercial Distribution

  • 00310742011234 ()


  • Lice treatment solution, synthetic
  • Lice comb, manual
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
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
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
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