Catalog Number

0703-070-000

Brand Name

Neptune E-SEP

Version/Model Number

0703-070-000

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

-

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

5f2903cc-74db-45d9-9d1a-2ee13042b833

Public Version Date

April 28, 2020

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

37613327297912

Quantity per Package

10

Contains DI Package

07613327297911

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack