Duns Number:152165700
Device Description: A tip starter kit containing 5 different single-use tips intended for use with Waterlase l A tip starter kit containing 5 different single-use tips intended for use with Waterlase laser delivery systems. The tips vary in core diameter and in length. The tips require sterilization prior to use.
Catalog Number
7230001
Brand Name
Waterlase Laser Tips
Version/Model Number
7230001
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)
Yes
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
506ab701-90a7-4f5f-adc4-4fc77a13a016
Public Version Date
July 29, 2020
Public Version Number
3
DI Record Publish Date
December 22, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 155 |