Catalog Number

0703-046-001

Brand Name

Neptune E-SEP

Version/Model Number

0703046001

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

64ef4deb-e53a-4738-bcda-d4a9a2a2caa9

Public Version Date

February 22, 2021

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

37613327117197

Quantity per Package

10

Contains DI Package

07613327117196

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack