Duns Number:102422578
Device Description: Single-use straight tip for use with the Pioneer Pro Diode Laser.
Catalog Number
-
Brand Name
Pioneer Pro Straight Tip
Version/Model Number
00668
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
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
K062619,K062619
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
3b7a3836-4e68-4867-a03c-f491315b5924
Public Version Date
November 08, 2018
Public Version Number
4
DI Record Publish Date
November 10, 2016
Package DI Number
00872320002558
Quantity per Package
20
Contains DI Package
00872320003388
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 |