Duns Number:144140845
Device Description: Disposa-Shield® Disposable Barrier Trial Pack For Cordless Prophy System Inner Module Cont Disposa-Shield® Disposable Barrier Trial Pack For Cordless Prophy System Inner Module Contains: 25 Disposable Polyethylene Barriers
Catalog Number
-
Brand Name
Disposa-Shield®
Version/Model Number
90789-1
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
7f9093dd-9716-4765-afec-4156c78fb68b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 27, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |