Duns Number:279456896
Device Description: HYGITECH's newest overshoes are not only waterproof but economically packaged in 250 pairs HYGITECH's newest overshoes are not only waterproof but economically packaged in 250 pairs. They protect the shoes of the dentists as well as the patients thanks to their impermeability. They also help to avoid all types of contaminations. Characteristics:-Waterproof-Unique Size 15x40-500 in a pack (250 pairs)-Non sterile, Single use-Blue
Catalog Number
HY-50021
Brand Name
HYGITECH
Version/Model Number
HY-50021
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
3627cc9d-0c6f-478d-839b-b1007d395af2
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
December 15, 2020
Package DI Number
03615140003056
Quantity per Package
10
Contains DI Package
03615140003049
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 |