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
M006L8406930
Brand Name
Flexiva Pulse ID
Version/Model Number
M006L8406930
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
b0826da8-f1e0-47ca-b39d-95c25cb524b0
Public Version Date
May 10, 2021
Public Version Number
1
DI Record Publish Date
May 01, 2021
Package DI Number
08714729978749
Quantity per Package
5
Contains DI Package
08714729978695
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 |