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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No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For Galaxy 7 Edge
In Commercial Distribution

  • 07290016650105 ()


  • Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For Galaxy 7
Not in Commercial Distribution

  • 07290016650082 ()


  • Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For Galaxy 6
In Commercial Distribution

  • 07290016650075 ()


  • Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For I-Phone 7
In Commercial Distribution

  • 07290016650068 ()


  • Motile sperm concentration IVD, kit, imaging, self-testing
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For I-Phone 6
In Commercial Distribution

  • 07290016650051 ()


  • Motile sperm concentration IVD, kit, imaging, self-testing
No Description
YOUNG DENTAL MANUFACTURING I, LLC
295096
In Commercial Distribution

  • 20302732950962 ()
  • 00302732950968 ()
295096

  • Dental coating, tooth-desensitizing
No Description
YOUNG DENTAL MANUFACTURING I, LLC
295095
In Commercial Distribution

  • 20302732950955 ()
  • 00302732950951 ()
295095

  • Dental coating, tooth-desensitizing
No Description
YOUNG DENTAL MANUFACTURING I, LLC
295094
In Commercial Distribution

  • 20302732950948 ()
  • 00302732950944 ()
295094

  • Dental coating, tooth-desensitizing
Arm Compression Pump (Full System) Premium
VIVE HEALTH LLC
RHB2098BLK
In Commercial Distribution

  • 10810113570713 ()
  • 00810113570716 ()


  • Portable sequential venous compression system
MICROPRIME G,UD,50
DANVILLE MATERIALS, LLC
94263
In Commercial Distribution

  • 00816594021617 ()
94263

  • Dental coating, tooth-desensitizing
MICROPRIME B,10ML,FA
DANVILLE MATERIALS, LLC
87001
In Commercial Distribution

  • 00816594021600 ()
87001

  • Dental coating, tooth-desensitizing
DEFEND DESENSITIZER 10ML
YOUNG MYDENT, LLC
DD-1000
In Commercial Distribution

  • 00816577022112 ()
DD-1000

  • Dental coating, tooth-desensitizing
Safco 5% fluoride varnish mint
SAFCO DENTAL SUPPLY CO.
102-8523
In Commercial Distribution

  • D723102852334 ()
  • D72310285233 ()
102-8523

  • Dental coating, tooth-desensitizing
Safco 5% fluoride varnish melon
SAFCO DENTAL SUPPLY CO.
102-8517
In Commercial Distribution

  • D723102851737 ()
  • D72310285173 ()
102-8517

  • Dental coating, tooth-desensitizing
Safco 5% fluoride varnish melon
SAFCO DENTAL SUPPLY CO.
102-8511
In Commercial Distribution

  • D72310285113 ()
  • D72310285110 ()
102-8511

  • Dental coating, tooth-desensitizing
Safco 5% fluoride varnish mint
SAFCO DENTAL SUPPLY CO.
102-8502
In Commercial Distribution

  • D72310285023 ()
  • D72310285020 ()
102-8502

  • Dental coating, tooth-desensitizing
Alpha-Ease® is a Hema/Gluteraldehyde desensitizer indicated for use on sensitive cavity preparations prior to the application of restorative material. It provides a physiological seal within the dentinal tubules by polymerization with the proteins in the tubules. The material provides virtually immediate relief from pain caused by hypersensitivity and is formulated with an antimicrobial to prevent microleakage. Kit Contains: 1 x 7ml Bottle
DENTAL TECHNOLOGIES, INC.
408.0101.002
In Commercial Distribution

  • D73540801010020 ()
408.0101.002

  • Dental coating, tooth-desensitizing
Alpha-Pro® White Varnish contains 5% sodium fluoride. It is used in the treatment of dental and post-operative sensitivity. Alpha-Pro White Varnish when applied practically becomes invisible, unlike traditional varnishes that cause unsightly yellow coloring of the teeth. Alpha-Pro White Varnish sets immediately on contact with saliva, leaving a smooth, thin layer. Kit Contains: 50 x 0.5ml Jars (Strawberry), 50 Applicator Brushes, Patient Instruction Pad, 50 "Keep Smiling" Stickers
DENTAL TECHNOLOGIES, INC.
407.0701.002
In Commercial Distribution

  • D73540707010010 ()
  • D73540707020010 ()
407.0701.002

  • Dental coating, tooth-desensitizing
Alpha-Pro® White Varnish contains 5% sodium fluoride. It is used in the treatment of dental and post-operative sensitivity. Alpha-Pro White Varnish when applied practically becomes invisible, unlike traditional varnishes that cause unsightly yellow coloring of the teeth. Alpha-Pro White Varnish sets immediately on contact with saliva, leaving a smooth, thin layer. Kit Contains: 50 x 0.5ml Jars (Melon), 50 Applicator Brushes, Patient Instruction Pad, 50 "Keep Smiling" Stickers
DENTAL TECHNOLOGIES, INC.
407.0601.002
In Commercial Distribution

  • D73540706010010 ()
  • D73540706020010 ()
407.0601.002

  • Dental coating, tooth-desensitizing
Alpha-Pro® White Varnish contains 5% sodium fluoride. It is used in the treatment of dental and post-operative sensitivity. Alpha-Pro White Varnish when applied practically becomes invisible, unlike traditional varnishes that cause unsightly yellow coloring of the teeth. Alpha-Pro White Varnish sets immediately on contact with saliva, leaving a smooth, thin layer. Kit Contains: 50 x 0.5ml Jars (Bubble Gum), 50 Applicator Brushes, Patient Instruction Pad, 50 "Keep Smiling" Stickers
DENTAL TECHNOLOGIES, INC.
407.0501.002
In Commercial Distribution

  • D73540705010010 ()
  • D73540705020010 ()
407.0501.002

  • Dental coating, tooth-desensitizing
No Description
Ningbo Albert Novosino Co.,Ltd.
1.0
In Commercial Distribution

  • 06971919469032 ()


  • Vaginal douche, reusable
LIQUID
KURARAY NORITAKE DENTAL INC.
#1217-KA
In Commercial Distribution

  • EKUR001217KA1 ()


  • Dental coating, tooth-desensitizing
POWDER
KURARAY NORITAKE DENTAL INC.
#1216-KA
In Commercial Distribution

  • EKUR001216KA1 ()


  • Dental coating, tooth-desensitizing
Introductory Set
KURARAY NORITAKE DENTAL INC.
#1215-KA
In Commercial Distribution

  • EKUR001215KA1 ()


  • Dental coating, tooth-desensitizing
Set
KURARAY NORITAKE DENTAL INC.
#1210-KA
In Commercial Distribution

  • EKUR001210KA1 ()


  • Dental coating, tooth-desensitizing
No Description
Hetaida Technology Co., Ltd
K5102US
In Commercial Distribution

  • 16970289035844 ()
  • 06970289035847 ()


  • Vaginal douche, reusable
No Description
Hetaida Technology Co., Ltd
K5102US
In Commercial Distribution

  • 16970289035646 ()
  • 06970289035649 ()


  • Vaginal douche, reusable
FluoriMax 2.5% NaF Varnish Salted CARAMEL Flavor Labeled Bottle
ELEVATE ORAL CARE, LLC
530MT1018
In Commercial Distribution

  • 00858290006215 ()
  • 00858290006253 ()
  • 00858290006246 ()
  • 00858290006260 ()

  • Total Volume: 12 Milliliter
530CM1018

  • Dental coating, tooth-desensitizing
Control Module,Kavo,OTC
A-DEC, INC.
54.0809.01
In Commercial Distribution

  • 10194665005450 ()
54.0809.01

  • Remotely-driven surgical/dental system drive cable
OTC Rechargeable Hearing Aid
Audicon Corporation
Torch
In Commercial Distribution

  • 10860010331078 ()
  • 00860010331071 ()


  • Air-conduction hearing aid, in-the-ear
OTC Rechargeable Hearing Aid
Audicon Corporation
Solid
In Commercial Distribution

  • 10860010331061 ()
  • 00860010331064 ()


  • Air-conduction hearing aid, behind-the-ear
OTC Rechargeable Hearing Aid
Audicon Corporation
Style
In Commercial Distribution

  • 00860010331057 ()
  • 10860010331054 ()


  • Air-conduction hearing aid, in-the-ear
OTC Rechargeable Hearing Aid
Audicon Corporation
Fusion
In Commercial Distribution

  • 00860010331026 ()
  • 10860010331023 ()
  • 20860010331020 ()
  • 40860010331024 ()


  • Air-conduction hearing aid, in-the-ear
OTC Rechargeable Hearing Aid
Audicon Corporation
Essential
In Commercial Distribution

  • 10860010331009 ()
  • 00860010331002 ()
CE-A39HT(White)

  • Air-conduction hearing aid, in-the-ear
OTC Combo TENS+EMS
GEMORE TECHNOLOGY CO., LTD.
GM540TE
In Commercial Distribution

  • 24712832961625 ()
  • 04712832961621 ()
GM540TE

  • Analgesic transcutaneous electrical nerve stimulation system
OTC Combo TENS+EMS
GEMORE TECHNOLOGY CO., LTD.
GM530TE
In Commercial Distribution

  • 24712832961595 ()
  • 04712832961591 ()
GM530TE

  • Analgesic transcutaneous electrical nerve stimulation system
OTC Combo TENS+EMS
GEMORE TECHNOLOGY CO., LTD.
GM520TE
In Commercial Distribution

  • 24712832961564 ()
  • 04712832961560 ()
GM520TE

  • Analgesic transcutaneous electrical nerve stimulation system
OTC Combo TENS+EMS
GEMORE TECHNOLOGY CO., LTD.
GM511TE
In Commercial Distribution

  • 24712832961533 ()
  • 04712832961539 ()
GM511TE

  • Analgesic transcutaneous electrical nerve stimulation system
OTC Combo TENS+EMS
GEMORE TECHNOLOGY CO., LTD.
GM510TE
In Commercial Distribution

  • 24712832961502 ()
  • 04712832961508 ()
GM510TE

  • Analgesic transcutaneous electrical nerve stimulation system
Wound & Skin Hydrogel OTC
Seriously Clean, Ltd.
221Z1
In Commercial Distribution

  • 00851608007539 ()


  • Antimicrobial wound irrigation solution
OTC Rechargeable Hearing Aid
Audicon Corporation
Core One Pro
In Commercial Distribution

  • 10850065321308 ()
  • 00850065321301 ()
CE-A90A(White)

  • Air-conduction hearing aid, in-the-ear
OTC Rechargeable Hearing Aid
Audicon Corporation
Core One Pro
In Commercial Distribution

  • 10850065321292 ()
  • 00850065321295 ()
CE-A90A(Black)

  • Air-conduction hearing aid, in-the-ear
OTC Rechargeable Hearing Aid
Audicon Corporation
Core One Pro
In Commercial Distribution

  • 10850065321261 ()
  • 00850065321264 ()
CE-A90A(skin)

  • Air-conduction hearing aid, in-the-ear
1T,FDA, OTC,1ng
Hangzhou AllTest Biotech Co., Ltd.
DFY-A102H A2553
In Commercial Distribution

  • 06936983149310 ()
USFTY1AT-1

  • Fentanyl IVD, kit, rapid ICT, clinical
Finger Pulse Oximeter, OTC
COMPASS HEALTH BRANDS CORP.
50052
Not in Commercial Distribution

  • 80092237604591 ()
  • 00092237604595 ()


  • Pulse oximeter probe, reusable
Finger Pulse Oximeter, OTC
COMPASS HEALTH BRANDS CORP.
50052
Not in Commercial Distribution

  • 00092237604595 ()
  • 30815067013372 ()
  • 00815067013371 ()


  • Pulse oximeter probe, reusable
STERILE OTC BASIC PACK
Cardinal Health 200, LLC
SBA5CBPGSB
In Commercial Distribution

  • 50887488789840 ()
  • 10887488789842 ()
SBA5CBPGSB

  • General surgical procedure kit, non-medicated, single-use
OTC Primer 1.5ml Bottle
PARKELL, INC.
S826
Not in Commercial Distribution

  • M595S8260 ()
S826

  • Denture reliner, soft, professional
Engage Android OTC Grey
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831481 ()
10094

  • Air-conduction hearing aid, receiver-in-the-ear
Engage MFI OTC Grey
HEARING LAB TECHNOLOGY, LLC
7595
In Commercial Distribution

  • 00810068831474 ()
10093

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