Duns Number:279456896
Device Description: These drapes are composed of 2 layers:1 absorbent spunlace layer (24g/m²)1 waterproof PP l These drapes are composed of 2 layers:1 absorbent spunlace layer (24g/m²)1 waterproof PP layer (30g/m²)More infoThey can cover the equipment, Mayo tables, bridge tables and the patient Sticking on the shorter sideFor the whole range SURFACES PROTECTIONFor the productEffective barrier to fight against cross contaminations in non autoclavable elements, like dental chairsProtection against bacteria and viruses, it allows to limit the use of disinfectants and makes the equipment last longer 3 sizes, for all purposesReally strong and tear-resistantCompliant with the 13795-3 European norm
Catalog Number
HY-634
Brand Name
HYGITECH
Version/Model Number
HY-634
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
KKX
Product Code Name
Drape, Surgical
Public Device Record Key
6a5e8e91-4cdb-4970-a8a9-797be2da2e3c
Public Version Date
December 15, 2020
Public Version Number
2
DI Record Publish Date
November 25, 2020
Package DI Number
03615140003827
Quantity per Package
15
Contains DI Package
03615140003810
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 |