Duns Number:279456896
Device Description: In order to prevent cross-contamination, all surfaces that are likely to be touched by the In order to prevent cross-contamination, all surfaces that are likely to be touched by the medical team during the surgery should be covered.The protection film helps fight cross-contamination by becoming a valid protection barrier for all the surfaces.Convenient: Easy to tear off and apply.Its delicate adhesive layer makes the protecttion film easily removable without damaging your equipment or walls.Supplied as a box of 50 adhesive sheets of 16 x 22.50 cm.
Catalog Number
HY-05702
Brand Name
HYGITECH
Version/Model Number
HY-05702
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
FTY
Product Code Name
Tape, Measuring, Rulers And Calipers
Public Device Record Key
d77e31c5-4b29-472c-97f4-ad7fe61526a3
Public Version Date
December 23, 2020
Public Version Number
1
DI Record Publish Date
December 15, 2020
Package DI Number
03615140002738
Quantity per Package
10
Contains DI Package
03615140002721
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 |