Catalog Number

-

Brand Name

A&E Medical / Disposable Suction Coagulator

Version/Model Number

050-050

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

K964621,K964621

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

9ae8bc45-f0d3-4d4e-9906-2293212d461e

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

November 23, 2016

Package DI Number

20841291105005

Quantity per Package

10

Contains DI Package

10841291105008

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-