Duns Number:447696675
Device Description: sterile and disposable protective barriers in water-repellent TNT, PVC, latex and polyuret sterile and disposable protective barriers in water-repellent TNT, PVC, latex and polyurethane for the treatment center, the quiver, the lamp handles, the control panels, the switches, the handpieces, the suction tubes, the end part of the X-rays , cameras, trays and instrument holders, contaminated waste containers, basins and swabs for disinfection.
Catalog Number
-
Brand Name
OMNISLEEVE
Version/Model Number
22.U0001.00
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
NRD
Product Code Name
Unit, Operative Dental, Accessories
Public Device Record Key
0e6da818-2419-4817-9c28-449e571a1d0a
Public Version Date
July 01, 2020
Public Version Number
1
DI Record Publish Date
June 23, 2020
Package DI Number
08056646502578
Quantity per Package
100
Contains DI Package
08056646502561
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 28 |