Duns Number:279456896
Device Description: Non-slip overshoesHYGITECHReference: HY-50019Superior quality: Non woven with a PE anti-sl Non-slip overshoesHYGITECHReference: HY-50019Superior quality: Non woven with a PE anti-slippery and waterproof sole
Catalog Number
HY-50019
Brand Name
HYGITECH
Version/Model Number
HY-50019
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
d27aeba1-8a6c-4339-bb9c-338842a574ac
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
December 15, 2020
Package DI Number
03615140003315
Quantity per Package
19
Contains DI Package
03615140003308
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 |