Duns Number:279456896
Device Description: The surgeon, the assistant and the patient all have the potential to bring dust and bacter The surgeon, the assistant and the patient all have the potential to bring dust and bacteria into the operating room. The mat contains 30 disposable sheets. Simply peel off and dispose of each sheet when soiled.To prevent the spreading of bacterial contamination from room to room, HYGITECH has created a mat with an acrylic sticky surface treated with a substance which attacks and neutralises the bacterial content present in the residues retained by the mat. Advantages:- Non-slip PVC base- Numbered layers for checking the remaining capacity- Dimensions : 60x120cm
Catalog Number
HY-058
Brand Name
HYGITECH
Version/Model Number
HY-058
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
17220d0f-25f0-42b6-a708-8beb85ada57a
Public Version Date
December 23, 2020
Public Version Number
1
DI Record Publish Date
December 15, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |