Duns Number:279456896
Device Description: Convenient- Easy to tear off and apply Its delicate adhesive layer makes Hygifilm easily r Convenient- Easy to tear off and apply Its delicate adhesive layer makes Hygifilm easily removable without damaging your equipment or walls.- Supplied as a roll of 10cm x 14,5xm pre-perforated adhesive sheets, presented in a dispenser box.In order to prevent cross-contamination, all surfaces that are likely to be touched by the medical team during the surgery should be covered. Hygifilm helps fight cross-contamination by isolating all surfaces that are impossible or difficult to autoclave: dental light handles, computer mice, computer control panel, keyboards and telephones.
Catalog Number
HY-057
Brand Name
HYGITECH
Version/Model Number
HY-057
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
c232c4df-19cf-40bc-bc5a-ecbea7cd3b64
Public Version Date
December 23, 2020
Public Version Number
1
DI Record Publish Date
December 15, 2020
Package DI Number
03615140000314
Quantity per Package
25
Contains DI Package
03615140000307
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 |