Duns Number:279456896
Device Description: The sterile sleeve provides excellent protection for tubing while guaranteeing the best sa The sterile sleeve provides excellent protection for tubing while guaranteeing the best sanitary conditions.It is easy to put on and fix.
Catalog Number
HY-139
Brand Name
HYGITECH
Version/Model Number
HY-139
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
5fe4e5ce-6bc6-4109-9e83-21cc37de053a
Public Version Date
December 15, 2020
Public Version Number
2
DI Record Publish Date
November 24, 2020
Package DI Number
03615140002448
Quantity per Package
10
Contains DI Package
03615140002431
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 |