Duns Number:381582196
Device Description: Satelec Handpiece GII is an autoclavable handpiece that is designed for the P5 Newtron®, P Satelec Handpiece GII is an autoclavable handpiece that is designed for the P5 Newtron®, P Max Newtron XS™, and Prophy Max™ ultrasonic generators.
Catalog Number
X12282
Brand Name
ACTEON
Version/Model Number
PAM ST GII R9002 & CG9C OEM
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
K050895
Product Code
ELC
Product Code Name
Scaler, Ultrasonic
Public Device Record Key
b0286efa-6d08-4376-8d5e-067561d0967b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 416 |