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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Powered wheelchair (mobility robot), Model: M4U; OTC
XSTO CO., LTD.
M4U
In Commercial Distribution

  • 06975052650111 ()


  • Electric-motor-driven wheelchair, occupant-controlled
Powered wheelchair (mobility robot), Model: M4; OTC
XSTO CO., LTD.
M4
In Commercial Distribution

  • 06975052650098 ()


  • Electric-motor-driven wheelchair, occupant-controlled
Mini-kit
TOKUYAMA DENTAL CORPORATION
15141
In Commercial Distribution

  • 04548190151417 ()


  • Dental cavity varnish
  • Dental coating, tooth-desensitizing
Refill
TOKUYAMA DENTAL CORPORATION
15121
In Commercial Distribution

  • 04548190151219 ()


  • Dental coating, tooth-desensitizing
  • Dental cavity varnish
Kit
TOKUYAMA DENTAL CORPORATION
15111
In Commercial Distribution

  • 04548190151110 ()


  • Dental cavity varnish
  • Dental coating, tooth-desensitizing
ChitoGauze is intended for temporary external use to stop bleeding in minor wounds.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 50870053000297 ()
  • 00870053000292 ()
1030

  • Chitosan haemostatic agent, professional, non-bioabsorbable
No Description
Sonoma Pharmaceuticals, Inc.
86012
In Commercial Distribution

  • 20850015491676 ()
  • 00850015491672 ()

  • Total Volume: 118 Milliliter
86012

  • Non-antimicrobial wound irrigation solution, multiple solute
No Description
Sonoma Pharmaceuticals, Inc.
86005
In Commercial Distribution

  • 20850015491492 ()
  • 00850015491498 ()

  • Total Volume: 59 Milliliter
86005

  • Non-antimicrobial wound irrigation solution, multiple solute
(Authentic Accessory) Bluetooth Earphones for OKB OTC Hearing Aid GV-SA03.60
OK BIOTECH CO., LTD.
HT001
In Commercial Distribution

  • 00193169003507 ()
30-81-0300-0303

  • Air-conduction hearing aid, in-the-ear
Topical burn and wound dressing, hydrogel barrier antimicrobial with silver and lidocaine, OTC indications, 1oz spray, pack of 15
Kericure Inc.
5031810C15
In Commercial Distribution

  • 00858071004195 ()
  • 00858071004904 ()


  • Wound hydrogel dressing, antimicrobial
Hearing Aid, Air-Conduction with Wireless Technology, OTC, Mach 1 Pro W OTC Hearing Aids - Charcoal, pair, 312 battery
Novidan, Inc.
99-0014-03
In Commercial Distribution

  • 00850049194099 ()


  • Air-conduction hearing aid, receiver-in-canal
Hearing Aid, Air-Conduction with Wireless Technology, OTC, Mach 1 Pro W OTC Hearing Aids - Slate, pair, 312 battery
Novidan, Inc.
99-0014-02
In Commercial Distribution

  • 00850049194082 ()


  • Air-conduction hearing aid, receiver-in-canal
Hearing Aid, Air-Conduction with Wireless Technology, OTC, Mach I Pro W OTC Hearing Aids - Beige, pair, 312 battery
Novidan, Inc.
99-0014-01
In Commercial Distribution

  • 00850049194075 ()


  • Air-conduction hearing aid, receiver-in-canal
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
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
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
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
Mach II Pro OTC Hearing Aids - Graphite Pair
Novidan, Inc.
99-0016-06
In Commercial Distribution

  • 00850049194426 ()


  • Air-conduction hearing aid, receiver-in-canal
Mach II Pro OTC Hearing Aids - Beige Pair
Novidan, Inc.
99-0016-05
In Commercial Distribution

  • 00850049194419 ()


  • Air-conduction hearing aid, receiver-in-canal
Mach II Pro OTC Hearing Aids - Glacier Pair
Novidan, Inc.
99-0016-04
In Commercial Distribution

  • 00850049194402 ()


  • Air-conduction hearing aid, receiver-in-canal
NoviOne RIC Rechargeable OTC Hearing Aids - Graphite Pair
Novidan, Inc.
99-0010-06
In Commercial Distribution

  • 00850049194396 ()


  • Air-conduction hearing aid, receiver-in-canal
NoviOne RIC Rechargeable OTC Hearing Aids - Beige Pair
Novidan, Inc.
99-0010-05
In Commercial Distribution

  • 00850049194389 ()


  • Air-conduction hearing aid, receiver-in-canal
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
Tala Android - OTC Hearing aid Ety part #20138
ETYMOTIC RESEARCH, INC.
Tala Android
In Commercial Distribution

  • 00846430005839 ()


  • Air-conduction hearing aid, in-the-ear
Tala MFI - OTC Hearing Aid Ety part# 20128
ETYMOTIC RESEARCH, INC.
TalaHA
In Commercial Distribution

  • 00846430005822 ()


  • Air-conduction hearing aid, in-the-ear
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
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
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
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
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
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
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
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
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
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