Duns Number:279456896
Device Description: Sterile transparent drape with adhesiveHYGITECHReference: HY-05902Practical for all surger Sterile transparent drape with adhesiveHYGITECHReference: HY-05902Practical for all surgeries, the transparent sterile drape with adhesive allows the protection of the implantology motor or the control unit without compromising the sterility of the surgery. The transparency ensures you can keep an eye on the indications shown on the screen and easily change the programme.More infoCharacteristics :• 1 waterproof layer of polyethylene (65g/m²)• Dimensions: 40 (width) cm x 50 (length) cm• Adhesive: Located along the width of the drape(40 x 5 cm)Waterproof protection of surfaces-Effective barrier to fight against cross contaminations in non autoclavable elements.- Protection against bacteria and viruses, it allows to limit the use of disinfectants and makes the equipment last longerSolidity- Resistant, does not tear
Catalog Number
HY-05902
Brand Name
HYGITECH
Version/Model Number
HY-05902
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
00603291-5546-4da1-a990-34bcfb7d85f2
Public Version Date
December 23, 2020
Public Version Number
1
DI Record Publish Date
December 15, 2020
Package DI Number
03615140003872
Quantity per Package
25
Contains DI Package
03615140003865
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 |