HYGITECH

Basic Information

Brand Name: HYGITECH
Primary DI: 03615140004480
Version / Model: HY-110009
Catalog Number: HY-110009
Company Name: HYGITECH
Labeler DUNS: 279456896
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2020-12-16
Public Version: 1
Public Version Date: 2020-12-24
Public Version Status: New
Public Device Record Key: 9d34ec57-d1a3-4d88-9e8c-a077f6cdaf3a

Device Description

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

Device Characteristics

Single Use: Yes
Prescription Use (Rx): No
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: Yes
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: Yes
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: Yes
Has Expiration Date: Yes
Has Donation ID: Yes

Sterilization

Is Sterile: Yes
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EFS	Unit, Oral Irrigation	Dental	872.6510	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12304	Oral lavage system	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status
Package	03615140004473	GS1	Box	10	In Commercial Distribution
Primary	03615140004480	GS1
Package	03615140004466	GS1	Carton	10	In Commercial Distribution