Duns Number:102422578
Device Description: Therapeutic treatment handpiece for use with the Pioneer Elite Diode Laser.
Catalog Number
002-00277
Brand Name
Pioneer Elite Therapy Handpiece
Version/Model Number
002-00277
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
ba00b89d-1d92-42ca-a182-ca2c4aa5aad0
Public Version Date
December 04, 2019
Public Version Number
4
DI Record Publish Date
November 10, 2016
Package DI Number
00872320004934
Quantity per Package
1
Contains DI Package
00872320002473
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 51 |