Catalog Number

E1455B-4

Brand Name

Edge

Version/Model Number

E1455B-4

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

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

K955836,K955836,K955836

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

c5bee3d2-144e-457d-888f-c5b51bc8fad4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 18, 2016

Package DI Number

10884521038493

Quantity per Package

24

Contains DI Package

20884521038490

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE