Duns Number:961656951
Device Description: The Canady Hybrid Plasma Scalpel is an electrosurgical plasma probe that is 2.3mm in diame The Canady Hybrid Plasma Scalpel is an electrosurgical plasma probe that is 2.3mm in diameter and 3.4m long. The electrosurgical plasma probe is used to coagulate biological tissue.
Catalog Number
-
Brand Name
Canady Plasma GIT Probe
Version/Model Number
AW-422538
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K052035
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
96513943-a0b4-4987-9031-e7ae9a770964
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
March 05, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |