Duns Number:481233849
Device Description: Instrument PSR x3
Catalog Number
-
Brand Name
PIEZON
Version/Model Number
DS-084A/T
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
-
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
K093000,K093000
Product Code
ELC
Product Code Name
Scaler, Ultrasonic
Public Device Record Key
5378a996-6a11-440e-aa55-181e58d96f77
Public Version Date
December 19, 2019
Public Version Number
1
DI Record Publish Date
December 11, 2019
Package DI Number
07613353181673
Quantity per Package
3
Contains DI Package
07613353183790
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 | 226 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| 3 | A medical device with high risk that requires premarket approval | 11 |