Catalog Number

-

Brand Name

A&E Medical / Disposable Bipolar Cords

Version/Model Number

050-200

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K930528,K930528

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

7c84238c-50c8-4063-984f-5d1c260595ae

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

November 29, 2016

Package DI Number

20841291105074

Quantity per Package

50

Contains DI Package

10841291105077

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-