Catalog Number

ECSTUS017G

Brand Name

EnCor®

Version/Model Number

ECSTUS017G

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

-

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

77106421-4122-4357-8f22-1ad90bc2f8ed

Public Version Date

September 20, 2021

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

10801741086394

Quantity per Package

5

Contains DI Package

00801741086397

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA