Catalog Number

-

Brand Name

Epix Electrosurgical Probe with Smoke Evacuation - L-Hook

Version/Model Number

CW002

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

-

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

12260736-63f5-4c1d-bedf-1d4ef0c9d0bc

Public Version Date

February 21, 2019

Public Version Number

2

DI Record Publish Date

June 26, 2018

Package DI Number

10607915136144

Quantity per Package

1

Contains DI Package

00607915136147

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-