Duns Number:279456896
Device Description: HYGITECH polyethylene protection sleeves enable you to cover hand pieces, cables, turbines HYGITECH polyethylene protection sleeves enable you to cover hand pieces, cables, turbines and contra-angles.Effective barrier to fight against cross contamination.Practical: Sleeves are easily separated one from another via the dispenser box.Resistant and easy to use.Sleeves must to be changed after every patientDimensions: 4.5 or 5,5cm x45 cm long, Ø2.8 cm, conical end Ø1.5cm
Catalog Number
HY-062
Brand Name
HYGITECH
Version/Model Number
HY-062
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
fb5bb6ec-c33b-4042-bb9c-b8c0bb5ecbd0
Public Version Date
December 23, 2020
Public Version Number
1
DI Record Publish Date
December 15, 2020
Package DI Number
03615140002868
Quantity per Package
18
Contains DI Package
03615140002851
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 |