HYGITECH - HYGITECH offers a complete range of irrigation - HYGITECH

Duns Number:279456896

Device Description: HYGITECH offers a complete range of irrigation sets compatible with most implantology mot 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 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

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More Product Details

Catalog Number

HY-110042

Brand Name

HYGITECH

Version/Model Number

HY-110042

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

EFS

Product Code Name

Unit, Oral Irrigation

Device Record Status

Public Device Record Key

b7b65039-f558-4a45-9799-f995d179b9a6

Public Version Date

December 23, 2020

Public Version Number

1

DI Record Publish Date

December 15, 2020

Additional Identifiers

Package DI Number

03615140001533

Quantity per Package

10

Contains DI Package

03615140001526

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"HYGITECH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 87
2 A medical device with a moderate to high risk that requires special controls. 8