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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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
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
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
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-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
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
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-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-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
First Aid Kit containing Medical Devices Class I and Drugs OTC: Elastic Band, Biohazard Bag, Antiseptic Wipes, Facemask with shield, Nitrile Gloves.
North Safety de Mexicali, S. de R. L. de C.V.
019746-0032L
In Commercial Distribution

  • 00821812030111 ()


  • First aid kit, medicated
First aid kit refill with Smart Compliance boxes. Contains first aid supplies to help treat minor injuries and includes ingestible OTC drugs.
Acme United Corporation
91112
In Commercial Distribution

  • 00092265911122 ()
91112

  • First aid kit, medicated
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
The LUSTRE 3XPREsS Light Beauty Therapy patches (Model: PR500l) is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
PR5001
In Commercial Distribution

  • 05060282690318 ()


  • Blue/red/infrared phototherapy lamp
The LUSTRE 3XPRESS Light Beauty Therapy patches (Model: PR6001) is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
PR6001
In Commercial Distribution

  • 05060282690301 ()


  • Blue/red/infrared phototherapy lamp
OTC hearing aids, behind-the-ear micro design, 4 preset hearing modes, 11 volume levels, with rechargeable lithium battery, charging case and power adapter included.
Voxx Accessories Corp.
RSH062SL
In Commercial Distribution

  • 00044476157424 ()


  • Air-conduction hearing aid, behind-the-ear
OTC hearing aids, behind-the-ear micro design, 4 preset hearing modes, 11 volume levels, with rechargeable lithium battery, charging case and power adapter included.
Voxx Accessories Corp.
RSH062BG
In Commercial Distribution

  • 00044476157417 ()


  • Air-conduction hearing aid, behind-the-ear
STATCUP II 12 Panel OTC Test Cup, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC, 1 test per box
MICRO DISTRIBUTING, L.C
STATII-71127-0-OTC
In Commercial Distribution

  • 00816036025418 ()
STATII-71127-0-OTC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
● It is a portable, battery-powered, transcutaneous electrical nerve stimulator (TENS device) that is intended for symptomatic relief of chronic intractable pain. ● OTC TENS Device.
WELL-LIFE HEALTHCARE LTD.
WL-2407
Not in Commercial Distribution

  • 04719872264071 ()


  • Physical therapy transcutaneous electrical stimulation system, line-powered
First Aid Kit containing Medical Devices Class I and Drugs OTC: Gauze Bandage, Tape Adhesive, Buffered Eye Wash, Scissor Bandage, Nitrile gloves, Burn Dressing.
North Safety de Mexicali, S. de R. L. de C.V.
019727-0014L
In Commercial Distribution

  • 00821812030289 ()


  • First aid kit, medicated
The LED Lip Perfector (Model: ZC-05) is an Over-the-Counter (OTC) device intended to treat fine lines and wrinkles and increase in circulation within the perioral region.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
ZC-05
In Commercial Distribution

  • 00655729008426 ()


  • Cosmetic red-light phototherapy system, home-use
1 TMT® Tourniquet 1 Hemostatic gauze (OTC) 2 Vented chest seal 1 Pre-Lubricated nasal airway 1 Compression dressing 1 Pair Exam gloves 1 Instruction guide
Safeguard US Operating, LLC
01
In Commercial Distribution

  • M6898723101011 ()
87-231-01

  • First aid kit, non-medicated, single-use
OTC hearing aids, behind-the-ear micro design, 4 preset hearing modes, 11 volume levels, with rechargeable lithium battery, charging case and power adapter included, IP22 water resistant.
Voxx Accessories Corp.
RSH072GY
In Commercial Distribution

  • 00044476158483 ()


  • Air-conduction hearing aid, behind-the-ear
OTC hearing aids, in-canal design, 4 pre-programmed environment modes + 6 volume levels with active noise reduction, built-in rechargeable lithium battery, charging case and power adapter included.
Voxx Accessories Corp.
RSH30BG
In Commercial Distribution

  • 00044476157523 ()


  • Air-conduction hearing aid, canal
Bluetooth-enabled wireless OTC hearing aids, behind-the-ear design, 4 preset hearing modes, IP54 water resistant, with built-in rechargeable lithium battery, keychain remote, charging case and power adapter included.
Voxx Accessories Corp.
RSH082GM
In Commercial Distribution

  • 00044476158605 ()


  • Air-conduction hearing aid, receiver-in-canal
Lexie B2, Powered by Bose re-chargeable self-fitting hearing aid
HEARX GROUP (PTY) LTD
Lexie B2 Self-fitting OTC Hearing Aids Powered by Bose
In Commercial Distribution

  • 10850022464642 ()
  • 00850022464645 ()
In-Store

  • Air-conduction hearing aid, receiver-in-canal
Lexie B1 Hearing Aids, powered by Bose. Self-fit, app-controlled hearing aids
HEARX GROUP (PTY) LTD
Lexie B1 Self-fitting OTC Hearing Aids Powered by Bose
In Commercial Distribution

  • 00850022464577 ()
  • 10850022464574 ()
In-Store

  • Air-conduction hearing aid, receiver-in-canal
First Aid Kit containing Medical Devices Class I and Drugs OTC: Ammonia Inhalants, Gauze Bandage, Triangular Bandage, Adhesive Tape, Bandage Compress, Burn Ointment, PVP wipes, Nitrile gloves, Scissors angled.
North Safety de Mexicali, S. de R. L. de C.V.
010998-4407
In Commercial Distribution

  • 00821812033785 ()


  • First aid kit, medicated
Barrier Bandage it’s intended to contain post-injection bleeding during a subcutaneous or intramuscular injection. The device is intended for healthcare professions (HCP) and lay users. The device is an OTC product.
HTL STREFA S A
n/a
In Commercial Distribution

  • 15907996099976 ()
  • 05907996099979 ()
  • 85907996099975 ()
6070

  • Skin adhesive protective material
First Aid Kit containing Drugs OTC and Medical Devices class I: Woven, Adhesive tape, Nitrile Gloves, Antiseptic Towelettes, Survival Blanket, Scissor bandage, Splinter Forceps, Bandage compress, CPR Mask, Triangular bandage, Gauze pads.
North Safety de Mexicali, S. de R. L. de C.V.
SF00001996
In Commercial Distribution

  • 00883940051529 ()


  • First aid kit, medicated
First Aid Kit containing Medical Devices class I and Drugs OTC: Triple Antibiotic, Triangular Bandage, Gauze Pads, Adhesive Tape, Gauze Compress, Cold Pack, Adhesive Bandage, PVP Iodine Wipes, Nitrile Gloves, Scissor Bandage.
North Safety de Mexicali, S. de R. L. de C.V.
019709-0005L
In Commercial Distribution

  • 00821812025193 ()


  • First aid kit, medicated
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