Duns Number:190377184
Device Description: Low Speed Long H.P. Cover 1 1/2" X 7 1/2"
Catalog Number
PS700
Brand Name
Plasdent
Version/Model Number
PS700
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K201604,K201604,K201604
Product Code
PEM
Product Code Name
Dental Barriers And Sleeves
Public Device Record Key
15131f8f-65c0-4baa-8d3d-3cdfc9e1d7c6
Public Version Date
July 08, 2022
Public Version Number
1
DI Record Publish Date
June 30, 2022
Package DI Number
D832PS7002
Quantity per Package
30
Contains DI Package
D832PS7001
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 | 750 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |