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.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
Catalog Number
HY-110018
Brand Name
HYGITECH
Version/Model Number
HY-110018
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
EFS
Product Code Name
Unit, Oral Irrigation
Public Device Record Key
e4fb4f79-cdde-40b0-8cd4-13d98d1350e8
Public Version Date
December 23, 2020
Public Version Number
1
DI Record Publish Date
December 15, 2020
Package DI Number
03615140001656
Quantity per Package
10
Contains DI Package
03615140001649
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |