Duns Number:021717889
Device Description: Flexiva Pulse and Flexiva Pulse TracTip laser fibers are high power single-use Flexiva Pulse and Flexiva Pulse TracTip laser fibers are high power single-use fiber
Catalog Number
M006L8405940
Brand Name
Flexiva Pulse
Version/Model Number
M006L8405940
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
1a765a41-534b-4241-8ca6-a5655a4c520c
Public Version Date
May 10, 2021
Public Version Number
1
DI Record Publish Date
May 01, 2021
Package DI Number
08714729978657
Quantity per Package
5
Contains DI Package
08714729978602
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 536 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8659 |
| 3 | A medical device with high risk that requires premarket approval | 1821 |
| U | Unclassified | 35 |