Duns Number:190377184
Device Description: Large Sensor Covers, 2 1/2"W X 9"L
Catalog Number
PS540
Brand Name
Plasdent
Version/Model Number
PS540
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
2c17e43f-4b0f-4a44-a157-df4ccf557309
Public Version Date
July 26, 2022
Public Version Number
1
DI Record Publish Date
July 18, 2022
Package DI Number
D832PS5402
Quantity per Package
20
Contains DI Package
D832PS5401
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 |