Catalog Number

E0509

Brand Name

Valleylab

Version/Model Number

E0509

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 10, 2020

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

c342c005-cc12-47c8-a8f2-cd65a9eb0fa3

Public Version Date

August 09, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

10884524000268

Quantity per Package

50

Contains DI Package

20884524000265

Package Discontinue Date

July 10, 2020

Package Status

Not in Commercial Distribution

Package Type

CASE