Duns Number:279456896
Device Description: The Surgical drapes consists in a protective barrier offering a resistance to bacteria p The Surgical drapes consists in a protective barrier offering a resistance to bacteria penetration during dental acts and an effective fluid control system in order to reduce the risk of surgical site infection.Sterile surgical Drapes are available in order to contribute and improve the preparation of the surgical room by preventing cross-contamination. It could be placed:On the patient: to cover the patient, the operated area during the surgical operation. It could also absorb exudate during the operation.On the operating room furniture which will be used as a support for any surgical instrumentation.The device is useful to protect the patient and environment’s surgeon.
Catalog Number
HY1-630
Brand Name
HYGITECH
Version/Model Number
HY1-630
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"
-
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
f8f15fff-c98c-4bfb-a19e-07b8858d0d25
Public Version Date
October 21, 2020
Public Version Number
1
DI Record Publish Date
October 13, 2020
Package DI Number
03615140003735
Quantity per Package
30
Contains DI Package
03615140003728
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 |