DEVICE: HYGITECH (03615140001526)
Device Identifier (DI) Information
HYGITECH
HY-110042
In Commercial Distribution
HY-110042
HYGITECH
HY-110042
In Commercial Distribution
HY-110042
HYGITECH
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
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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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.
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FDA Product Code
[?]Product Code | Product Code Name |
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EFS | Unit, Oral Irrigation |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
b7b65039-f558-4a45-9799-f995d179b9a6
December 23, 2020
1
December 15, 2020
December 23, 2020
1
December 15, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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03615140001533 | 10 | 03615140001526 | In Commercial Distribution | Box | |
03615140001540 | 10 | 03615140001533 | In Commercial Distribution | Carton |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined