Duns Number:279456896
Device Description: Dental chair covers provide an effective barrier against bacteria, protecting the patient Dental chair covers provide an effective barrier against bacteria, protecting the patient from cross-infection. HYGITECH supplies both sterile and non-sterile chair covers. Benefits: For the surgeon: Cost effective: These covers reduce the need to use disinfectants and protect the dental chair from bacteria, increasing the lifespan of the chair. Convenient: A single, universal, easy-to-use cover for all 3 parts of the dental chair (6 fixing straps) For the patient: Comfortable and waterproof: it creates a pleasant looking and hygienic environment, giving the patient a feeling of safety and cleanliness.
Catalog Number
HY-60042
Brand Name
HYGITECH
Version/Model Number
HY-60042
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
c800681d-0447-4a53-a6fe-39d6757af640
Public Version Date
June 22, 2021
Public Version Number
4
DI Record Publish Date
November 25, 2020
Package DI Number
03615140003643
Quantity per Package
30
Contains DI Package
03615140003636
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 |