Duns Number:080354039
Device Description: Bendable disposable tips (assortment of 25 tips) for use with AMD LASERS' Picasso Line of Bendable disposable tips (assortment of 25 tips) for use with AMD LASERS' Picasso Line of Soft-Tissue Dental Lasers. Contains ten (10) 400um core diameter 5mm length tips, ten (10) 400um core diameter 10mm length tips, and five (5) 300um core diameter 10mm length tips. All tips are pre-bent to 60 degree angle.
Catalog Number
TIP25
Brand Name
AMD LASERS Bendable Disposable Tips (Assortment of 25)
Version/Model Number
TIP25
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 31, 2020
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
a7aa1769-4bbf-4f07-bb18-4ae9187bb30a
Public Version Date
November 03, 2020
Public Version Number
4
DI Record Publish Date
September 20, 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. | 18 |