Catalog Number

ESE1650

Brand Name

MEDLINE

Version/Model Number

ESE1650

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

K931338,K931338

Product Code

HGI

Product Code Name

ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)

Public Device Record Key

839e6027-e3c4-40bf-87a8-d51005bd96b9

Public Version Date

October 04, 2021

Public Version Number

2

DI Record Publish Date

November 14, 2020

Package DI Number

20193489198703

Quantity per Package

10

Contains DI Package

10193489198706

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE