Duns Number:102422578
Device Description: Picasso Optical Fiber Tip; 400um diameter; 10mm long. For use with the Picasso family of d Picasso Optical Fiber Tip; 400um diameter; 10mm long. For use with the Picasso family of diode lasers.
Catalog Number
-
Brand Name
Picasso Tips_400um diam_10mm long
Version/Model Number
03809
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
b3abb413-33ce-4f69-b276-6e8c6fdfab6a
Public Version Date
November 08, 2018
Public Version Number
2
DI Record Publish Date
September 17, 2018
Package DI Number
00872320004194
Quantity per Package
25
Contains DI Package
00872320004361
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 |