Duns Number:344267187
Device Description: Vaporflex® Probe 250, Ball Tip, Bipolar
Catalog Number
-
Brand Name
Vaporflex®
Version/Model Number
JVP25024
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"
Yes
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
K161378,K161378
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
0a1e325a-6e46-49b8-b77e-96e70ac67628
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 08, 2016
Package DI Number
04250337113850
Quantity per Package
5
Contains DI Package
04250337113843
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 293 |