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.
Catalog Number
HY-110034
Brand Name
HYGITECH
Version/Model Number
HY-110034
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
5d709440-6388-49b2-8d62-211aae36bb79
Public Version Date
December 15, 2020
Public Version Number
2
DI Record Publish Date
November 24, 2020
Package DI Number
03615140001564
Quantity per Package
10
Contains DI Package
03615140001557
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 |