HYGITECH

Primary DI
03615140004459
Brand
HYGITECH
Company
HYGITECH
Model
HY-110022
Catalog number
HY-110022
Device description
Sterile irrigation setHYGITECHReference: HY-110022HYGITECH 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 flowAccessories 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.ConditioningEach 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
Published
2020-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EFSUnit, Oral Irrigation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFSUnit, Oral IrrigationDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03615140004435PackageGS110In Commercial Distribution
03615140004442PackageGS110In Commercial Distribution
03615140004459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03615140004435036151400044353615140004435
03615140004442036151400044423615140004442
03615140004459036151400044593615140004459

GMDN Terms#

Term, Definition table
TermDefinition
Oral lavage systemAn assembly of devices intended for automated or semi-automated irrigation and washing of tissue/debris from teeth, gums, and other parts of the oral cavity (e.g., tongue) through application of pulsed jets of non-medicated liquids (e.g., mouthwash, water), to maintain oral hygiene; it may in addition be intended for nasal lavage. It consists of a central mains electricity (AC-powered) unit with a reservoir and pump, and a number of hand-held applicators, each typically designed to clean a specific oral anatomy (e.g., tongue, braces, gum line). It is normally available [non-prescription] over-the-counter (OTC) for use in the home and dental office.

Regulatory Flags#

DUNS number
279456896
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03615140002875HYGITECHHY-064HY-0642020-12-15
03615140002899HYGITECHHY-066HY-0662020-12-15
03615140003247HYGITECHHY-50013HY-500132020-12-15
03615140003568HYGITECHHY-50018HY-500182020-12-15
03615140003612HYGITECHHY-50016HY-500162020-12-15
03615140003728HYGITECHHY1-630HY1-6302020-10-13
03615140000116HYGITECHHY-90078HY-900782020-12-14
03615140000307HYGITECHHY-057HY-0572020-12-15
03615140000321HYGITECHHY-055HY-0552020-12-15
03615140002721HYGITECHHY-05702HY-057022020-12-15
03615140002837HYGITECHHY-060HY-0602020-12-15
03615140002851HYGITECHHY-062HY-0622020-12-15
03615140002561HYGITECHHY-130012HY-1300122020-11-24
03615140002592HYGITECHHY-130025HY-1300252020-12-15
03615140004534HYGITECHHY-130014HY-1300142020-12-16
03615140003261HYGITECHHY-50015HY-500152020-12-15
03615140003094HYGITECHHY-525HY-5252020-11-25
03615140003124HYGITECHHY-604HY-6042020-11-25
03615140003155HYGITECHHY-607HY-6072020-11-25
03615140003186HYGITECHHY-60033HY-600332020-11-25

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