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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Enamelast Syringe 20pk - Cool Mint
ULTRADENT PRODUCTS, INC.
4348
Not in Commercial Distribution

  • 00883205102867 ()
4348

  • Dental coating, tooth-desensitizing
Enamelast Syringe 2pk - Cool Mint
ULTRADENT PRODUCTS, INC.
4349
Not in Commercial Distribution

  • 00883205102850 ()
4349

  • Dental coating, tooth-desensitizing
Enamelast Unit Dose 5pk - Cool Mint
ULTRADENT PRODUCTS, INC.
4354
In Commercial Distribution

  • 00883205102843 ()
4354

  • Dental coating, tooth-desensitizing
Enamelast Syringe 20pk - Orange Cream
ULTRADENT PRODUCTS, INC.
4347
Not in Commercial Distribution

  • 00883205102812 ()
4347

  • Dental coating, tooth-desensitizing
Enamelast Syringe 2pk - Orange Cream
ULTRADENT PRODUCTS, INC.
4346
Not in Commercial Distribution

  • 00883205102805 ()
4346

  • Dental coating, tooth-desensitizing
Enamelast Unit Dose 5pk - Orange Cream
ULTRADENT PRODUCTS, INC.
4345
In Commercial Distribution

  • 00883205102799 ()
4345

  • Dental coating, tooth-desensitizing
UltraEZ Tray Delivery, Upper/Lower Combo Kit
ULTRADENT PRODUCTS, INC.
5721
In Commercial Distribution

  • 00883205102690 ()
5721

  • Dental coating, tooth-desensitizing
UltraEz Mini Kit
ULTRADENT PRODUCTS, INC.
5743
In Commercial Distribution

  • 00883205102652 ()
5743

  • Dental coating, tooth-desensitizing
Enamelast Unit Dose 5pk - Walterberry
ULTRADENT PRODUCTS, INC.
4526
In Commercial Distribution

  • 00883205101754 ()
4526

  • Dental coating, tooth-desensitizing
Enamelast 200pk Application Brushes
ULTRADENT PRODUCTS, INC.
4529
In Commercial Distribution

  • 00883205021533 ()
4529

  • Dental coating, tooth-desensitizing
Enrich BTE OTC
HEARING LAB TECHNOLOGY, LLC
Enrich
In Commercial Distribution

  • 00810068831436 ()
10081

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

  • 20860010331099 ()
  • 00860010331095 ()
  • 10860010331092 ()
  • 30860010331096 ()


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

  • 10860010331030 ()
  • 00860010331033 ()
  • 20860010331037 ()
  • 30860010331034 ()


  • Air-conduction hearing aid, behind-the-ear
1T, FDA OTC
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 06936983167116 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
1T, FDA OTC
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 06936983155748 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
1T, FDA OTC
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 06936983155144 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Pulse Ox OTC
VERIDIAN HEALTHCARE LLC
21602
In Commercial Distribution

  • 00682891216021 ()


  • Pulse oximeter
Pulse Ox OTC
VERIDIAN HEALTHCARE LLC
21601
In Commercial Distribution

  • 00682891216014 ()


  • Pulse oximeter
Pulse Ox OTC
VERIDIAN HEALTHCARE LLC
21600
In Commercial Distribution

  • 00682891216007 ()


  • Pulse oximeter
OTC Hearing Aid
Audicon Corporation
Nexus
In Commercial Distribution

  • 10850065321018 ()
  • 00850065321011 ()
  • 20850065321015 ()


  • Air-conduction hearing aid, behind-the-ear
Sterile irrigation set HYGITECH Reference: HY-110009 Packaging : Box of 10 HYGITECH offers a complete range of irrigation sets compatible with most implantology motors on the market. Irrigation is an essential element of an implant surgery and limits the heating of bone and adjacent tissues. To avoid thermal damage to the bone, the surgical drill must be properly cooled with the proper flow of coolant; this flow rate can be set directly on the motor. It will be imperative to use a suitable and compatible irrigation set for an implantology motor in particular. Each HYGITECH irrigation set is equipped with: A perforator, for the sterile solution bag, and an ON / OFF air filter to increase the flow of the saline solution. A flow control wheel to control or cut the flow of the solution. A silicone peristaltic pump tube adapted to the dimensions of each physio dispenser. A stopcock that is present on some references to regulate the different flow Accessories in reference functions: S-shaped fasteners: attaches the irrigation tube to the micro motor cord. Hooks: When the diameter of the implantology cord is large, use these hooks to attach it to the irrigation set. Y connector: to choose between one or two channels. The dentist can use a single lane for internal or external irrigation or both lanes to irrigate simultaneously internally and externally. Conditioning Each irrigation set is packaged in a sterile blister pack. There are two traceability labels on each blister: these labels include the batch number, reference, and expiration date of the product to facilitate the transfer of information to the patient record. Box of 10 sets. All brand names are registred trademarks and property of the manufacturer
HYGITECH
HY-110009
In Commercial Distribution

  • 03615140004473 ()
  • 03615140004480 ()
  • 03615140004466 ()
HY-110009

  • Oral lavage system
Sterile irrigation set HYGITECH Reference: HY-110022 HYGITECH offers a complete range of irrigation sets compatible with most implantology motors on the market. Irrigation is an essential element of an implant surgery and limits the heating of bone and adjacent tissues. To avoid thermal damage to the bone, the surgical drill must be properly cooled with the proper flow of coolant; this flow rate can be set directly on the motor. It will be imperative to use a suitable and compatible irrigation set for an implantology motor in particular. Each HYGITECH irrigation set is equipped with: A perforator, for the sterile solution bag, and an ON / OFF air filter to increase the flow of the saline solution. A flow control wheel to control or cut the flow of the solution. A silicone peristaltic pump tube adapted to the dimensions of each physio dispenser. A stopcock that is present on some references to regulate the different flow Accessories in reference functions: S-shaped fasteners: attaches the irrigation tube to the micro motor cord. Hooks: When the diameter of the implantology cord is large, use these hooks to attach it to the irrigation set. Y connector: to choose between one or two channels. The dentist can use a single lane for internal or external irrigation or both lanes to irrigate simultaneously internally and externally. Conditioning Each irrigation set is packaged in a sterile blister pack. There are two traceability labels on each blister: these labels include the batch number, reference, and expiration date of the product to facilitate the transfer of information to the patient record. Box of 10 sets. All brand names are registred trademarks and property of the manufacturer
HYGITECH
HY-110022
In Commercial Distribution

  • 03615140004442 ()
  • 03615140004459 ()
  • 03615140004435 ()
HY-110022

  • Oral lavage system
Sterile irrigation set HYGITECH Reference: HY-110011 HYGITECH offers a complete range of irrigation sets compatible with most implantology motors on the market. Irrigation is an essential element of an implant surgery and limits the heating of bone and adjacent tissues. To avoid thermal damage to the bone, the surgical drill must be properly cooled with the proper flow of coolant; this flow rate can be set directly on the motor. It will be imperative to use a suitable and compatible irrigation set for an implantology motor in particular. Each HYGITECH irrigation set is equipped with: A perforator, for the sterile solution bag, and an ON / OFF air filter to increase the flow of the saline solution. A flow control wheel to control or cut the flow of the solution. A silicone peristaltic pump tube adapted to the dimensions of each physio dispenser. A stopcock that is present on some references to regulate the different flow Accessories in reference functions: S-shaped fasteners: attaches the irrigation tube to the micro motor cord. Hooks: When the diameter of the implantology cord is large, use these hooks to attach it to the irrigation set. Y connector: to choose between one or two channels. The dentist can use a single lane for internal or external irrigation or both lanes to irrigate simultaneously internally and externally. Conditioning Each irrigation set is packaged in a sterile blister pack. There are two traceability labels on each blister: these labels include the batch number, reference, and expiration date of the product to facilitate the transfer of information to the patient record. Box of 10 sets. All brand names are registred trademarks and property of the manufacture
HYGITECH
HY-110011
In Commercial Distribution

  • 03615140004053 ()
  • 03615140004046 ()
  • 03615140004060 ()
HY-110011

  • Oral lavage system
Sterile irrigation set HYGITECH Reference: HY-110007 HYGITECH offers a complete range of irrigation sets compatible with most implantology motors on the market. Irrigation is an essential element of an implant surgery and limits the heating of bone and adjacent tissues. To avoid thermal damage to the bone, the surgical drill must be properly cooled with the proper flow of coolant; this flow rate can be set directly on the motor. It will be imperative to use a suitable and compatible irrigation set for an implantology motor in particular. Each HYGITECH irrigation set is equipped with: A perforator, for the sterile solution bag, and an ON / OFF air filter to increase the flow of the saline solution. A flow control wheel to control or cut the flow of the solution. A silicone peristaltic pump tube adapted to the dimensions of each physio dispenser. A stopcock that is present on some references to regulate the different flow Accessories in reference functions: S-shaped fasteners: attaches the irrigation tube to the micro motor cord. Hooks: When the diameter of the implantology cord is large, use these hooks to attach it to the irrigation set. Y connector: to choose between one or two channels. The dentist can use a single lane for internal or external irrigation or both lanes to irrigate simultaneously internally and externally. Conditioning Each irrigation set is packaged in a sterile blister pack. There are two traceability labels on each blister: these labels include the batch number, reference, and expiration date of the product to facilitate the transfer of information to the patient record. Box of 10 sets. All brand names are registred trademarks and property of the manufacturer
HYGITECH
HY-110007
In Commercial Distribution

  • 03615140004022 ()
  • 03615140004015 ()
  • 03615140004039 ()
HY-110007

  • Oral lavage system
Sterile irrigation set HYGITECH Reference: HY-110003 HYGITECH offers a complete range of irrigation sets compatible with most implantology motors on the market. Irrigation is an essential element of an implant surgery and limits the heating of bone and adjacent tissues. To avoid thermal damage to the bone, the surgical drill must be properly cooled with the proper flow of coolant; this flow rate can be set directly on the motor. It will be imperative to use a suitable and compatible irrigation set for an implantology motor in particular. Each HYGITECH irrigation set is equipped with: A perforator, for the sterile solution bag, and an ON / OFF air filter to increase the flow of the saline solution. A flow control wheel to control or cut the flow of the solution. A silicone peristaltic pump tube adapted to the dimensions of each physio dispenser. A stopcock that is present on some references to regulate the different flow Accessories in reference functions: S-shaped fasteners: attaches the irrigation tube to the micro motor cord. Hooks: When the diameter of the implantology cord is large, use these hooks to attach it to the irrigation set. Y connector: to choose between one or two channels. The dentist can use a single lane for internal or external irrigation or both lanes to irrigate simultaneously internally and externally. Conditioning Each irrigation set is packaged in a sterile blister pack. There are two traceability labels on each blister: these labels include the batch number, reference, and expiration date of the product to facilitate the transfer of information to the patient record. Box of 10 sets. All brand names are registred trademarks and property of the manufacturer
HYGITECH
HY-110003
In Commercial Distribution

  • 03615140003995 ()
  • 03615140003988 ()
  • 03615140004008 ()
HY-110003

  • Oral lavage system
HYGITECH offers a complete range of irrigation sets compatible with most implantology motors on the market. Irrigation is an essential element of an implant surgery and limits the heating of bone and adjacent tissues.
HYGITECH
HY-110028
In Commercial Distribution

  • 03615140001748 ()
  • 03615140001731 ()
  • 03615140001755 ()
HY-110028

  • Oral lavage system
HYGITECH offers a complete range of irrigation sets compatible with most implantology motors on the market. Irrigation is an essential element of an implant surgery and limits the heating of bone and adjacent tissues. To avoid thermal damage to the bone, the surgical drill must be properly cooled with the proper flow of coolant; this flow rate can be set directly on the motor. It will be imperative to use a suitable and compatible irrigation set for an implantology motor in particular. Each HYGITECH irrigation set is equipped with: A perforator, for the sterile solution bag, and an ON / OFF air filter to increase the flow of the saline solution. A flow control wheel to control or cut the flow of the solution. A silicone peristaltic pump tube adapted to the dimensions of each physio dispenser. A stopcock that is present on some references to regulate the different flow Accessories in reference functions: S-shaped fasteners: attaches the irrigation tube to the micro motor cord. Hooks: When the diameter of the implantology cord is large, use these hooks to attach it to the irrigation set. Y connector: to choose between one or two channels. The dentist can use a single lane for internal or external irrigation or both lanes to irrigate simultaneously internally and externally. Conditioning Each irrigation set is packaged in a sterile blister pack. There are two traceability labels on each blister: these labels include the batch number, reference, and expiration date of the product to facilitate the transfer of information to the patient record. Box of 10 sets. All brand names are registred trademarks and property of the manufacturer
HYGITECH
HY-110005
In Commercial Distribution

  • 03615140001717 ()
  • 03615140001700 ()
  • 03615140001724 ()
HY-110005

  • Oral lavage system
HYGITECH offers a complete range of irrigation sets compatible with most implantology motors on the market. Irrigation is an essential element of an implant surgery and limits the heating of bone and adjacent tissues.
HYGITECH
HY-110054
In Commercial Distribution

  • 03615140001687 ()
  • 03615140001670 ()
  • 03615140001694 ()
HY-110054

  • Oral lavage system
HYGITECH offers a complete range of irrigation sets compatible with most implantology motors on the market. Irrigation is an essential element of an implant surgery and limits the heating of bone and adjacent tissues. Each HYGITECH irrigation set is equipped with: A perforator, for the sterile solution bag, and an ON / OFF air filter to increase the flow of the saline solution. A flow control wheel to control or cut the flow of the solution. A silicone peristaltic pump tube adapted to the dimensions of each physio dispenser. A stopcock that is present on some references to regulate the different flow Accessories in reference functions: S-shaped fasteners: attaches the irrigation tube to the micro motor cord. Hooks: When the diameter of the implantology cord is large, use these hooks to attach it to the irrigation set. Y connector: to choose between one or two channels. The dentist can use a single lane for internal or external irrigation or both lanes to irrigate simultaneously internally and externally. Conditioning Each irrigation set is packaged in a sterile blister pack. There are two traceability labels on each blister: these labels include the batch number, reference, and expiration date of the product to facilitate the transfer of information to the patient record. Box of 10 sets. All brand names are registred trademarks and property of the manufacturer
HYGITECH
HY-110018
In Commercial Distribution

  • 03615140001656 ()
  • 03615140001649 ()
  • 03615140001663 ()
HY-110018

  • Oral lavage system
HYGITECH offers a complete range of irrigation sets compatible with most implantology motors on the market. Irrigation is an essential element of an implant surgery and limits the heating of bone and adjacent tissues.
HYGITECH
HY-110001
In Commercial Distribution

  • 03615140001625 ()
  • 03615140001618 ()
  • 03615140001632 ()
HY-110001

  • Oral lavage system
HYGITECH offers a complete range of irrigation sets compatible with most implantology motors on the market. Irrigation is an essential element of an implant surgery and limits the heating of bone and adjacent tissues.
HYGITECH
HY-110014
In Commercial Distribution

  • 03615140001595 ()
  • 03615140001588 ()
  • 03615140001601 ()
HY-110014

  • Oral lavage system
HYGITECH offers a complete range of irrigation sets compatible with most implantology motors on the market. Irrigation is an essential element of an implant surgery and limits the heating of bone and adjacent tissues.
HYGITECH
HY-110034
In Commercial Distribution

  • 03615140001564 ()
  • 03615140001557 ()
  • 03615140001571 ()
HY-110034

  • Oral lavage system
HYGITECH offers a complete range of irrigation sets compatible with most implantology motors on the market. Irrigation is an essential element of an implant surgery and limits the heating of bone and adjacent tissues. To avoid thermal damage to the bone, the surgical drill must be properly cooled with the proper flow of coolant; this flow rate can be set directly on the motor. It will be imperative to use a suitable and compatible irrigation set for an implantology motor in particular. Each HYGITECH irrigation set is equipped with: A perforator, for the sterile solution bag, and an ON / OFF air filter to increase the flow of the saline solution. A flow control wheel to control or cut the flow of the solution. A silicone peristaltic pump tube adapted to the dimensions of each physio dispenser. A stopcock that is present on some references to regulate the different flow Accessories in reference functions: S-shaped fasteners: attaches the irrigation tube to the micro motor cord. Hooks: When the diameter of the implantology cord is large, use these hooks to attach it to the irrigation set. Y connector: to choose between one or two channels. The dentist can use a single lane for internal or external irrigation or both lanes to irrigate simultaneously internally and externally. Conditioning Each irrigation set is packaged in a sterile blister pack. There are two traceability labels on each blister: these labels include the batch number, reference, and expiration date of the product to facilitate the transfer of information to the patient record. Box of 10 sets. All brand names are registred trademarks and property of the manufacturer
HYGITECH
HY-110042
In Commercial Distribution

  • 03615140001533 ()
  • 03615140001526 ()
  • 03615140001540 ()
HY-110042

  • Oral lavage system
MINI TRAVEL B/O TOOTHBRUSH
FOURSTAR GROUP INC.
64431566F
In Commercial Distribution

  • 00049696880145 ()


  • Ionic electric toothbrush
LUMINANT BO TB W/REMOVEABLE HD
FOURSTAR GROUP INC.
11012436DA
In Commercial Distribution

  • 00049696736701 ()


  • Ionic electric toothbrush
Black
Gurunanda, LLC
HM100
In Commercial Distribution

  • 00810051087048 ()


  • Oral lavage system
No Description
Gurunanda, LLC
RK100
In Commercial Distribution

  • 00810051086843 ()


  • Oral lavage system
Device R3100A 4.0 + 6 CMW Pods
Gurunanda, LLC
R3100A 4.0
In Commercial Distribution

  • 00810051086515 ()


  • Oral lavage system
Lavender
Gurunanda, LLC
HM100
In Commercial Distribution

  • 00810051086317 ()


  • Oral lavage system
No Description
Gurunanda, LLC
R3100
In Commercial Distribution

  • 00810051085839 ()


  • Oral lavage system
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