Catalog Number

-

Brand Name

Edge

Version/Model Number

E1465-4

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

K981916,K981916,K981916

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

a08671d4-2234-4818-bd16-14d8b2df26ce

Public Version Date

May 13, 2022

Public Version Number

4

DI Record Publish Date

November 18, 2016

Package DI Number

10884521175525

Quantity per Package

24

Contains DI Package

20884521175522

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE