Duns Number:102422578
Device Description: Single-use 600um optical fiber tip for use with the Pilot Diode Laser.
Catalog Number
-
Brand Name
Pilot Diode Laser 600um Tip
Version/Model Number
03093
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)
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
3300651e-d66c-446e-85e9-917aabeda43f
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
November 10, 2016
Package DI Number
00872320002268
Quantity per Package
50
Contains DI Package
00872320003364
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 |