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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BEIGE/990035-SWH; set of Sontro Self-Fitting OTC Hearing Aids (Model AI-S); self-fit, streaming, app-controlled hearing aids
Soundwave Hearing, LLC
990035-SWH
In Commercial Distribution

  • 00850016231109 ()


  • Air-conduction hearing aid, receiver-in-canal
GREY/990008-SWH; left (refurbished) replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990008-SWH
In Commercial Distribution

  • 00850016231086 ()


  • Air-conduction hearing aid, receiver-in-canal
GREY/990007-SWH; right (refurbished) replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990007-SWH
In Commercial Distribution

  • 00850016231079 ()


  • Air-conduction hearing aid, receiver-in-canal
GREY/990005-SWH; left replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990005-SWH
In Commercial Distribution

  • 00850016231055 ()


  • Air-conduction hearing aid, receiver-in-canal
GREY/990004-SWH; right replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990004-SWH
In Commercial Distribution

  • 00850016231048 ()


  • Air-conduction hearing aid, receiver-in-canal
GREY/990002-SWH; set of Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990002-SWH
In Commercial Distribution

  • 00850016231024 ()


  • Air-conduction hearing aid, receiver-in-canal
GREY/990030-SWH; set of Sontro Self-Fitting OTC Hearing Aids (Model AI-S); self-fit, streaming, app-controlled hearing aids
Soundwave Hearing, LLC
990030-SWH
In Commercial Distribution

  • 00850016231000 ()


  • Air-conduction hearing aid, receiver-in-canal
BEIGE/990017-SWH; left (refurbished) replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990017-SWH
In Commercial Distribution

  • 00850016231178 ()


  • Air-conduction hearing aid, receiver-in-canal
BEIGE/990016-SWH; right (refurbished) replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990016-SWH
In Commercial Distribution

  • 00850016231161 ()


  • Air-conduction hearing aid, receiver-in-canal
BEIGE/990014-SWH; left replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990014-SWH
In Commercial Distribution

  • 00850016231147 ()


  • Air-conduction hearing aid, receiver-in-canal
ChitoGauze is intended for temporary external use to stop bleeding in minor wounds.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 50870053000303 ()
  • 00870053000308 ()
1025

  • Chitosan haemostatic agent, professional, non-bioabsorbable
Wound Irrigation
Bionix, LLC
601
Not in Commercial Distribution

  • 20859911004027 ()
  • 00859911004023 ()
601

  • Wound shield
Porcelain Powder for clinical use.
Kulzer GmbH
66008770
Not in Commercial Distribution

  • J014660155890 ()
66008770

  • Dental appliance fabrication material, ceramic
InTENSity Mini Pack Eletrodes 2x2 white cloth 4/pk OTC
COMPASS HEALTH BRANDS CORP.
EP2020WC2-INTM-2
In Commercial Distribution

  • 00092237623916 ()


  • Transcutaneous electrical stimulation electrode, single-use
6mL NeoConnect Enteral Syringe with ENFit Connector, Non-Sterile, OTC
NEOMED, INC.
Neo6
In Commercial Distribution

  • 20817584013210 ()
  • 10817584013213 ()
  • 00817584013216 ()
Neo6

  • ENFit oral/enteral syringe, reusable
3mL NeoConnect Enteral Syringe with ENFit Connector, Non-Sterile, OTC
NEOMED, INC.
Neo3
In Commercial Distribution

  • 20817584013203 ()
  • 10817584013206 ()
  • 00817584013209 ()
Neo3

  • ENFit oral/enteral syringe, reusable
60mL NeoConnect Enteral Syringe with ENFit Connector, Non-Sterile, OTC
NEOMED, INC.
Neo60
In Commercial Distribution

  • 10817584013237 ()
  • 00817584013230 ()
  • 20817584013234 ()
Neo60

  • ENFit oral/enteral syringe, reusable
12mL NeoConnect Enteral Syringe with ENFit Connector, Non-Sterile, OTC
NEOMED, INC.
Neo12
In Commercial Distribution

  • 20817584013227 ()
  • 10817584013220 ()
  • 00817584013223 ()
Neo12

  • ENFit oral/enteral syringe, reusable
No Description
Sonoma Pharmaceuticals, Inc.
84873
In Commercial Distribution

  • 20189116000068 ()
  • 00189116000064 ()

  • Total Volume: 237 Milliliter
84873

  • Non-antimicrobial wound irrigation solution, multiple solute
ManaFlexx 2 is the only NMES device designed for ease of use by eliminating wires or standalone electrodes. This device is single patient use and is designed for use in the home to treat muscle atrophy due to lack of use or surgery. Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions Completely portable no wires or bulky devices Can be placed anywhere treatment is desired Battery operated Reusable - simply replace pads and batteries
Manamed, Inc.
Manaflexx 2 OTC
In Commercial Distribution

  • 00810113683218 ()
MF002-OTC

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Over the counter air conduction hearing aid
EAR TECHNOLOGY CORPORATION
Focus+T otc
In Commercial Distribution

  • 00810323009631 ()


  • Air-conduction hearing aid, behind-the-ear
No Description
Huizhou Jinghao Medical Technology Co., Ltd
OTC CIC Recharge
In Commercial Distribution

  • 16971094537400 ()
  • 06971094537403 ()


  • Air-conduction hearing aid, receiver-in-the-ear
No Description
PHILIPS ORAL HEALTHCARE, LLC
HX8424/50
In Commercial Distribution

  • 00075020085696 ()


  • Water jet flosser
  • Basic electric toothbrush
No Description
PHILIPS ORAL HEALTHCARE, LLC
HX8492/42
In Commercial Distribution

  • 00075020084088 ()


  • Basic electric toothbrush
  • Water jet flosser
No Description
PHILIPS ORAL HEALTHCARE, LLC
HX8492/41
In Commercial Distribution

  • 00075020084071 ()


  • Basic electric toothbrush
  • Water jet flosser
No Description
PHILIPS ORAL HEALTHCARE, LLC
HX8492/40
In Commercial Distribution

  • 00075020084064 ()


  • Water jet flosser
  • Basic electric toothbrush
No Description
PHILIPS ORAL HEALTHCARE, LLC
HX8454/81
In Commercial Distribution

  • 00075020079053 ()


  • Water jet flosser
  • Basic electric toothbrush
No Description
PHILIPS ORAL HEALTHCARE, LLC
HX8273/20
In Commercial Distribution

  • 00075020078230 ()


  • Water jet flosser
  • Basic electric toothbrush
No Description
PHILIPS ORAL HEALTHCARE, LLC
HX8218/02
In Commercial Distribution

  • 00075020064738 ()


  • Water jet flosser
  • Basic electric toothbrush
No Description
PHILIPS ORAL HEALTHCARE, LLC
HX6214/50
In Commercial Distribution

  • 00075020052889 ()


  • Basic electric toothbrush
  • Water jet flosser
FEEDING SYRINGE, ENFIT, FLT TP, OTC
MEDLINE INDUSTRIES, INC.
ENFIT70660
In Commercial Distribution

  • 40193489036658 ()
  • 00193489036650 ()
ENFIT70660

  • ENFit oral/enteral syringe, single-use
OTC, HEARING AID, IN EAR, BLACK
MEDLINE INDUSTRIES, INC.
MDSHEARAIDBK1
In Commercial Distribution

  • 20197344013248 ()
  • 00197344013244 ()
  • 80197344013240 ()
MDSHEARAIDBK1

  • Air-conduction hearing aid, in-the-ear
OTC, HEARING AID, BEHIND EAR, WT
MEDLINE INDUSTRIES, INC.
MDSHEARAIDWT1
In Commercial Distribution

  • 00197344013275 ()

  • Width: 10.5 Millimeter
  • Length: 33.1 Millimeter
  • MDSHEARAIDWT
MDSHEARAIDWT1

  • Air-conduction hearing aid, behind-the-ear
1T, FDA OTC, Without Absorbent wick
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 06936983155151 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
1T, cut-off:1ng/ml,FDA OTC
Hangzhou AllTest Biotech Co., Ltd.
DFY-A102H A1617
In Commercial Distribution

  • 06936983148504 ()
DISP-FY-102H

  • Fentanyl IVD, kit, rapid ICT, clinical
Lucid Hearing OTC Hearing Protection #20055
ETYMOTIC RESEARCH, INC.
Lucid Hearing OTC #20055
In Commercial Distribution

  • 00846430005662 ()


  • Earplugs, reusable
Tubing,Motor,Long,A-dec 501,OTC
A-DEC, INC.
54.0854.01
In Commercial Distribution

  • 10194665005603 ()
54.0854.01

  • Remotely-driven surgical/dental system drive cable
Tubing,Motor,Medium,A-dec 501,OTC
A-DEC, INC.
54.0853.01
In Commercial Distribution

  • 10194665005580 ()
54.0853.01

  • Remotely-driven surgical/dental system drive cable
Tubing,Motor,Short,A-dec 501,OTC
A-DEC, INC.
54.0852.01
In Commercial Distribution

  • 10194665005573 ()
54.0852.01

  • Remotely-driven surgical/dental system drive cable
Kit,Tubing ASSY,Long,Kavo,OTC
A-DEC, INC.
54.0808.01
In Commercial Distribution

  • 10194665005511 ()
54.0808.01

  • Remotely-driven surgical/dental system drive cable
Kit,Tubing ASSY,Medium,Kavo,OTC
A-DEC, INC.
54.0807.01
In Commercial Distribution

  • 10194665005504 ()
54.0807.01

  • Remotely-driven surgical/dental system drive cable
Tubing,Control Motor,Long,Kavo,OTC
A-DEC, INC.
54.0847.00
In Commercial Distribution

  • 10194665004163 ()
54.0847.00

  • Dental surgical power tool motor, electric
Tubing,Control Motor,Medium,Kavo,OTC
A-DEC, INC.
54.0846.00
In Commercial Distribution

  • 10194665004149 ()
54.0846.00

  • Dental surgical power tool motor, electric
Electric Motor,Nano,68 IN,OTC
A-DEC, INC.
54.0727.01
In Commercial Distribution

  • 10194665001278 ()
54.0727.01

  • Dental surgical power tool motor, electric
Electric Motor,Nano,61 IN,OTC
A-DEC, INC.
54.0446.01
In Commercial Distribution

  • 10194665000813 ()
54.0446.01

  • Dental surgical power tool motor, electric
Safer Lock - Rx Locking Cap OTC
Rxguardian Inc.
1000092
In Commercial Distribution

  • 00860002613611 ()


  • Medicine bottle
  • Medicine bottle cap
BTE OTC Hearing Aids, Pair - Charcoal
Novidan, Inc.
99-0019-03
In Commercial Distribution

  • 00850049194129 ()


  • Air-conduction hearing aid, behind-the-ear
BTE OTC Hearing Aids, Pair - Slate
Novidan, Inc.
99-0019-02
In Commercial Distribution

  • 00850049194112 ()


  • Air-conduction hearing aid, behind-the-ear
BTE OTC Hearing Aids, Pair - Beige
Novidan, Inc.
99-0019-01
In Commercial Distribution

  • 00850049194105 ()


  • Air-conduction hearing aid, behind-the-ear
OTC Single Use urinary test strip
REESE PHARMACEUTICAL COMPANY
UTES
In Commercial Distribution

  • 00023513000039 ()
  • 00036800468450 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
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