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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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
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
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
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
Dental Tool Kit, 1 Dental Scaler, 1 Mirror, 1 Dental Pick, and 1 Tongue Cleaner
WALGREEN CO.
203666
In Commercial Distribution

  • 10311917197378 ()
  • 00311917197371 ()


  • Dental mirror, reusable
  • Periodontal pick/brush, reusable
  • Tongue scraper, reusable
  • Manual dental scaler, reusable
Dental Tool Kit
Topco Associates, LLC
XES
In Commercial Distribution

  • 10036800442242 ()
  • 00036800442245 ()


  • Dental mirror, reusable
  • Manual dental scaler, reusable
  • Periodontal pick/brush, reusable
  • Tongue scraper, reusable
Dental Tool Kit
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
1T8
In Commercial Distribution

  • 00050428272695 ()


  • Dental mirror, reusable
  • Manual dental scaler, reusable
  • Periodontal pick/brush, reusable
  • Tongue scraper, reusable
Dentemp SleepTight in an OTC anti-snoring mouthpiece intended for use by adults as an aid to reduce snoring.
Doc Brands, Inc.
1
In Commercial Distribution

  • 00372494103452 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
CLOSED-LARGE/991016-SWH; 10-pc blister pack of replacement ear domes for RIC used on Sontro Self-Fitting OTC Hearing Aids
Soundwave Hearing, LLC
991016-SWH
In Commercial Distribution

  • 00850016231345 ()


  • Earmould, preformed
CLOSED-MEDIUM/991015-SWH; 10-pc blister pack of replacement ear domes for RIC used on Sontro Self-Fitting OTC Hearing Aids
Soundwave Hearing, LLC
991015-SWH
In Commercial Distribution

  • 00850016231338 ()


  • Earmould, preformed
CLOSED-SMALL/991014-SWH; 10-pc blister pack of replacement ear domes for RIC used on Sontro Self-Fitting OTC Hearing Aids
Soundwave Hearing, LLC
991014-SWH
In Commercial Distribution

  • 00850016231321 ()


  • Earmould, preformed
OPEN-LARGE/991012-SWH; 10-pc blister pack of replacement ear domes for RIC used on Sontro Self-Fitting OTC Hearing Aids
Soundwave Hearing, LLC
991012-SWH
In Commercial Distribution

  • 00850016231307 ()


  • Earmould, preformed
OPEN-MEDIUM/991011-SWH; 10-pc blister pack of replacement ear domes for RIC used on Sontro Self-Fitting OTC Hearing Aids
Soundwave Hearing, LLC
991011-SWH
In Commercial Distribution

  • 00850016231291 ()


  • Earmould, preformed
OPEN-SMALL/991010-SWH; 10-pc blister pack of replacement ear domes for RIC used on Sontro Self-Fitting OTC Hearing Aids
Soundwave Hearing, LLC
991010-SWH
In Commercial Distribution

  • 00850016231284 ()


  • Earmould, preformed
Battery powered, home use (OTC) diode laser indicated for use in the treatment of periorbital and perioral wrinkles.
Tanda Beauty Canada, Inc
HU-FG01751
In Commercial Distribution

  • 00806248007296 ()


  • Cosmetic red-light phototherapy system, home-use
Battery powered, home use (OTC) diode laser indicated for use in the treatment of periorbital and perioral wrinkles.
Tanda Beauty Canada, Inc
HU-CO00621
In Commercial Distribution

  • 10806248006333 ()
  • 00806248006336 ()
HU-CO00621

  • Cosmetic red-light phototherapy system, home-use
Battery powered, home use (OTC) diode laser indicated for use in the treatment of periorbital and perioral wrinkles.
Tanda Beauty Canada, Inc
HU-FG00851US
In Commercial Distribution

  • 10806248005329 ()
  • 00806248005322 ()
HU-FG00851US

  • Cosmetic red-light phototherapy system, home-use
The HP Hearing PRO self-fitting air conduction hearing aid for Over-the-Counter (OTC) sale to consumers in the new OTC product classification QUH. HP Hearing PRO OTC hearing aids are intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. They are adjusted by the user to meet the user’s hearing needs. No pre-programming or hearing test is necessary.
NUHEARA LIMITED
NU320-02
In Commercial Distribution

  • 00850000562004 ()


  • Air-conduction hearing aid, in-the-ear
TULIP-ONE SIZE (12MM)/991013-SWH; 10-pc blister pack of replacement ear domes for RIC used on Sontro Self-Fitting OTC Hearing Aids
Soundwave Hearing, LLC
991013-SWH
In Commercial Distribution

  • 00850016231314 ()


  • Earmould, preformed
First Aid Kit containing Drugs OTC and Medical Devices class I: Wipe Alcohol Pre Pad, Sting relief wipes, Plastic Bandage,
North Safety de Mexicali, S. de R. L. de C.V.
019741-0028L
In Commercial Distribution

  • 00821812030388 ()


  • First aid kit, medicated
The LED Eye Perfector (Model: EY-36A) is an Over-the-Counter (OTC) device intended for use in treating wrinkles within the periorbital region
Shenzhen Kaiyan Medical Equipment Co,. Ltd
EY-36A
In Commercial Distribution

  • 00655729008266 ()


  • Cosmetic red-light phototherapy system, home-use
The LED Eye mask (Model: A20) is an Over-the-Counter (OTC) device intended for use in treating wrinkles within the periorbital region.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
A20
In Commercial Distribution

  • 00628176949581 ()


  • Cosmetic red-light phototherapy system, home-use
The LED Eve Mask (Model: EY-20R) is an Over-the-Counter (OTc) device intended for use in treating wrinkles within the periorbital region.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
EY-20R
In Commercial Distribution

  • 06970006971144 ()


  • Blue/red/infrared phototherapy lamp
RESPONDER® Polysaccharide Hemostat OTC is indicated for the local management of bleeding such as minor lacerations, minor cuts and minor abrasions.
Starch Medical Inc.
RP0003
In Commercial Distribution

  • 00899010002698 ()
  • 00899010002865 ()


  • Plant polysaccharide haemostatic agent, bioabsorbable
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