Canady Plasma GIT Side Fire Probe - The Canady Hybrid Plasma GIT Side Fire probe is - US MEDICAL INNOVATIONS, LLC

Duns Number:961656951

Device Description: The Canady Hybrid Plasma GIT Side Fire probe is an electrosurgical plasma probe that is 2. The Canady Hybrid Plasma GIT Side Fire probe is an electrosurgical plasma probe that is 2.3 mm in diameter and 2.3 m long. The electrosurgical plasma probe is used to coagulate biological tissue.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Canady Plasma GIT Side Fire Probe

Version/Model Number

AW-422540

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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

K052035

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

daab5a39-f463-4e9b-90ae-de7508389fb2

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

March 05, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"US MEDICAL INNOVATIONS, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 7