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

  • 00050428454442 ()


  • First aid kit, medicated
First Aid Kit Containing class I medical devices and OTC drugs
Adventure Ready Brands
1
In Commercial Distribution

  • 00050428442630 ()


  • First aid kit, medicated
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
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
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
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
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
991019-SWH; retention lock for RIC used on Sontro Self-Fitting OTC Hearing Aids
Soundwave Hearing, LLC
991019-SWH
In Commercial Distribution

  • 00850016231352 ()


  • Ear pip
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
An Android platform mobile application to adjust NoviMed wireless OTC hearing aids.
Novidan, Inc.
99-0011-09
In Commercial Distribution

  • 00850049194006 ()


  • Air-conduction hearing aid, receiver-in-canal
CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
CORETESTS, INC.
ACT21002-4
In Commercial Distribution

  • 10850042559564 ()
  • 00850042559567 ()
  • 00850042559543 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
CORETESTS, INC.
ACT21002-2
In Commercial Distribution

  • 10850042559557 ()
  • 00850042559550 ()
  • 00850042559543 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
CORETESTS, INC.
ACT21002-5
In Commercial Distribution

  • 10850042559533 ()
  • 00850042559536 ()
  • 00850042559543 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
CORETESTS, INC.
ACT21002-1
In Commercial Distribution

  • 00850042559529 ()
  • 10850042559526 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
BloodSTOP OTC Hemostat, 8 pcs 1"X1"(2.5cmx2.5cm), 2pcs 2"x2" (5cmX5cm)
Lifescience Plus, Inc.
BS-OTC-28
In Commercial Distribution

  • 30850744001297 ()
  • 00850744001296 ()
  • 10850744001293 ()

  • Area/Surface Area: 1 Square inch
  • Area/Surface Area: 4 Square inch
BS-OTC-28

  • Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial
Over-The-Counter (OTC) Transcutaneous Electrical Nerve Stimulator (TENS) - Club Pack size - Back & Hip
CHATTEM, INC.
SmartRelief 1.0 - Club Pack
In Commercial Distribution

  • 00041167080818 ()


  • Transcutaneous electrical stimulation electrode, single-use
Over-The-Counter (OTC) Transcutaneous Electrical Nerve Stimulator (TENS) - Knee and Shoulder refill electrode
CHATTEM, INC.
SmartRelief 1.0 - Knee/Shoulder Refill
In Commercial Distribution

  • 00041167080498 ()


  • Transcutaneous electrical stimulation electrode, single-use
Over-The-Counter (OTC) Transcutaneous Electrical Nerve Stimulator (TENS) - Back and Hip refill electrode
CHATTEM, INC.
SmartRelief 1.0 - Back/Hip Refill
In Commercial Distribution

  • 00041167080467 ()


  • Transcutaneous electrical stimulation electrode, single-use
INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use) THC
ALFA SCIENTIFIC DESIGNS, INC.
03-4705OT
In Commercial Distribution

  • 10796918002072 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Dentemp Oral Care Kit contains the tools to keep that just from the dentist clean between dental visits. Safely and effectively clean the surface of the teeth with the dental scaler. Remove food particles from between the teeth with the Dental Pick. Use the Tongue Cleaner to help remove the germs that cause bad breath.
Doc Brands, Inc.
1
In Commercial Distribution

  • 00372494102271 ()


  • Manual dental scaler, reusable
  • Dental mirror, reusable
  • Tongue scraper, reusable
No Description
POS-T-VAC INC
Esteem Classic OTC International System
In Commercial Distribution

  • 00857312008367 ()
XX02

  • Penile vacuum device
WoundClot is a soluble dressing, based on cellulosic structure. In contact with liquids it forms absorbent gel which adheres to the wound surface to control bleeding. WoundClot is intended to be used as a topical dressing for minor skin surface bleeding wounds such as minor cuts and minor abrasions.
CORE SCIENTIFIC CREATIONS LTD
3" X 39" OTC FDA
Not in Commercial Distribution

  • 17290016339304 ()
  • 07290016339307 ()
101581901

  • Plant polysaccharide haemostatic agent, bioabsorbable
Lexie Hearing Club (Lexie B2 Self-fitting OTC Hearing Aids, Powered by Bose Bundle)
HEARX GROUP (PTY) LTD
Lexie B2 Self-fitting OTC Hearing Aids, Powered by Bose
Not in Commercial Distribution

  • 00850022464942 ()


  • Air-conduction hearing aid, receiver-in-canal
An iOS mobile application used to adjust Sonify Hearing wireless OTC hearing aids.
Novidan, Inc.
99-0011-08
In Commercial Distribution

  • 00850049194037 ()


  • Air-conduction hearing aid, receiver-in-canal
An Android mobile application used to adjust Sonify Hearing wireless OTC hearing aids.
Novidan, Inc.
99-0011-07
In Commercial Distribution

  • 00850049194020 ()


  • Air-conduction hearing aid, receiver-in-canal
An iOS platform mobile application used to adjust NoviMed wireless OTC hearing aids.
Novidan, Inc.
99-0011-10
In Commercial Distribution

  • 00850049194013 ()


  • Air-conduction hearing aid, receiver-in-canal
REF: ABTDOAO17701A, FDA OTC, 1T/kit, AMP500/COC150/FYL1/MDMA500/MET500/MOP300/THC50
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 06936983177689 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
StimChoice 4000 OTC 4-channel portable device with TENS/EMS/Fitness and Sports modes
COMPASS HEALTH BRANDS CORP.
E400-6R
In Commercial Distribution

  • 80092237622052 ()
  • 00092237622056 ()
  • 30092237622057 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
OneStop™ Bandage is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations and minor abrasions and in patients on anticoagulation therapy. It also provides an antibacterial barrier against a wide range of gram positive and gram negative organisms.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 00870053000360 ()
  • 50870053000365 ()
1112

  • Chitosan haemostatic agent, professional, non-bioabsorbable
A rapid immunochromatographic assay for the qualitative detection of Luteinizing Hormone (LH) surge for the detection of ovulation and fertility. For over-the-counter use. The test reagent is exposed to urine, allowing urine to migrate through the absorbent test strip. The labeled antibody-dye conjugate binds to the LH in the specimen forming an antibody-antigen complex. This complex binds to the anti-LH antibody in the test region (T) and produces a colored line. In the absence of LH, there is no color line in the test region (T). The reaction mixture continues flowing through the absorbent device past the test region (T) and control region (C), producing a colored line, demonstrating that the test strip is functioning correctly. The test strip can accurately detect your LH surge when the concentration of LH is equal to or greater than 25mIU/ml.
NOVODX Corporation
GN013ST
Not in Commercial Distribution

  • 00850059915424 ()
GN013ST25-US

  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
1-Midstream DoCheck Wide Tip;1 per box;hCG Pregnancy Test 25 mIU/mL OTC
WONDFO USA CO., LTD.
DW1-M-DW
In Commercial Distribution

  • 10816862024323 ()
  • 00816862024326 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
First Aid Kit Refill for Smart Compliance XXL Business Kits without ingestible OTC medications
Acme United Corporation
91115
In Commercial Distribution

  • 00092265911153 ()
91115

  • First aid kit, medicated
First Aid Kit Refill, SmartCompliance Refill for XXL Business Kit containing ingestible OTC Drugs
Acme United Corporation
91114
In Commercial Distribution

  • 00092265911146 ()
91114

  • First aid kit, medicated
InTENSity at Home OTC TENS device with 12 preset programs and 100 Intensity levels
COMPASS HEALTH BRANDS CORP.
E200-6R
In Commercial Distribution

  • 30092237619590 ()
  • 00092237619599 ()
  • 80092237619595 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
US Professional Dental Sample Kit comprised of 1 x 525PHS Deep Clean Technique Toothbrush 1x 2030PQA Expanding Floss 1 x 828PQ Twisted Mint Flosser 1 x 872PQ Proxabrush Tight Interdental Brush 1 x 3612PQ Proxabrush Moderate Interdental Brush 1 x 650PA Soft Pick Advanced Interdental Pick 1 x 308PD End Tuft Toothbrush 1 x 600PYC Rubber Tip Stimulator 1 x 760PB Tongue Cleaner /Scraper 1 x 895 PQ Crayola Kids Flosser 1 x 227A Crayola Marker Toothbrush
SUNSTAR AMERICAS, INC.
KIT59
In Commercial Distribution

  • 00070942007849 ()


  • Periodontal pick/brush, reusable
  • Basic manual toothbrush
  • Dental floss
  • Tongue scraper, reusable
AESTHETIC - Floor Model Low Level Laser -- 12 diodes 640nm 17mW - OTC (Non-prescriptive) - IFU Reduction Circumference
ERCHONIA CORPORATION, LLC
JZB
In Commercial Distribution

  • 00858985006261 ()


  • Low-intensity laser fat liquefaction system
SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel 1 ng/ml OTC; 25 Test/Box
WONDFO USA CO., LTD.
DWFTY-OTC1-25BX
In Commercial Distribution

  • 10816862026136 ()
  • 00816862026139 ()
  • 00816862026122 ()


  • Fentanyl IVD, kit, rapid ICT, clinical
SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel 1 ng/ml OTC; 10 Test/Box
WONDFO USA CO., LTD.
DWFTY-OTC1-10BX
In Commercial Distribution

  • 10816862026112 ()
  • 00816862026115 ()
  • 00816862026108 ()


  • Fentanyl IVD, kit, rapid ICT, clinical
SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel 1 ng/ml OTC; 5 Test/Box
WONDFO USA CO., LTD.
DWFTY-OTC1-5BX
In Commercial Distribution

  • 10816862026099 ()
  • 00816862026092 ()
  • 00816862026085 ()


  • Fentanyl IVD, kit, rapid ICT, clinical
1 iFOB Fecal Occult Blood Test OTC; 1 Cassettes + 1 Collection Tube + 1 Collection Paper
WONDFO USA CO., LTD.
WFOB-OTC-1BX
In Commercial Distribution

  • 10816862025979 ()
  • 00816862025972 ()


  • Faecal occult blood IVD, kit, rapid ICT, clinical
First Aid Kit Refill for SmartCompliance XL Business first aid kits without ingestible OTC drugs
Acme United Corporation
91113
In Commercial Distribution

  • 00092265911139 ()
91113

  • First aid kit, medicated
EMPACT 6+ Patient Hard Case Kit with Wall Cabinet OTC - Tactical & Medical Kit. Tactical side has Bat Flash Light, TAC-WEGE, TAC-KEYS and other Tactical components that can be used in an active shooter RUN, HIDE, Fight situation. Medical side has bleeding control Kits featuring Hemostatic Dressing and other Trauma First- Aid equipment.
Pro1tek
B283E6HCXOB0
In Commercial Distribution

  • B283E6HCXOB0 ()


  • First aid kit, medicated
AESTHETIC - Floor Model Low Level Laser -- 8 diodes 405nm 25mW - OTC (Non-prescriptive) - IFU Reduction Circumference/Fat
ERCHONIA CORPORATION, LLC
VZ8
In Commercial Distribution

  • 00858985006292 ()


  • Low-intensity laser fat liquefaction system
AESTHETIC - Floor Model Low Level Laser -- 6 diodes 635nm 17mW - OTC (Non-prescriptive) - IFU Reduction Circumference/Fat
ERCHONIA CORPORATION, LLC
SHR
In Commercial Distribution

  • 00858985006124 ()
SHR

  • Low-intensity laser fat liquefaction system
The DemarkQ is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.
Light Tree Ventures Europe B.V.
P19-0007
In Commercial Distribution

  • 08720299044227 ()


  • Red/blue light phototherapy unit
Hygiene Kit; Each Kit Includes Comb, 2 oz Mouthwash, 4 oz Shampoo/Body Wash, .85 oz Shaving Cream, .85 oz Toothpaste and Toothbrush.
Bosma Enterprises
10-7225
In Commercial Distribution

  • 10818634020908 ()
  • 00818634020901 ()
10-7225

  • Personal care kit
  • Basic manual toothbrush
  • Dental mouthwash
  • Liquid skin soap
INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use) AMP COC MET MOR PCP THC MDMA(XTC)
ALFA SCIENTIFIC DESIGNS, INC.
03-4703OT
In Commercial Distribution

  • 10796918002065 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use) AMP BAR BUP BZD COC MET MOR MTD OXY300 PCP THC MDMA(XTC)
ALFA SCIENTIFIC DESIGNS, INC.
03-4701OT
In Commercial Distribution

  • 10796918002058 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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