Duns Number:144140845
Device Description: Disposa-Shield® Disposable Barrier For Cordless Prophy System Inner Module
Catalog Number
-
Brand Name
Disposa-Shield®
Version/Model Number
A88019
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PEM
Product Code Name
Dental barriers and sleeves
Public Device Record Key
46386418-af0e-45b4-a143-a61ba0b669f2
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 11, 2016
Package DI Number
D003A880192
Quantity per Package
12
Contains DI Package
D003A880191
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 156 |