Duns Number:279456896
Device Description: HYGITECH header cover in polyethylene enables you to cover the armchair header in your den HYGITECH header cover in polyethylene enables you to cover the armchair header in your dental practice.It can also cover the x-ray tube. It is an effective barrier to fight against cross contaminations.Practical: easily separated one from the other through the dispenser box.Resistant Easy to set upThe head cover must to be changed after every patient.Dimensions: 23cm large x 30cm long
Catalog Number
HY-064
Brand Name
HYGITECH
Version/Model Number
HY-064
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
FXP
Product Code Name
Cover, Shoe, Operating-Room
Public Device Record Key
7089d5a6-3609-43f2-97a0-6be3b8e626d3
Public Version Date
December 23, 2020
Public Version Number
1
DI Record Publish Date
December 15, 2020
Package DI Number
03615140002882
Quantity per Package
8
Contains DI Package
03615140002875
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| 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 |