Catalog Number

EGA11

Brand Name

ENSEAL

Version/Model Number

EGA11

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

-

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

55fdb295-62d5-41c1-9b3c-69b534630229

Public Version Date

November 03, 2021

Public Version Number

3

DI Record Publish Date

July 15, 2016

Package DI Number

30705036013888

Quantity per Package

25

Contains DI Package

20705036013881

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE