Catalog Number

-

Brand Name

Valleylab

Version/Model Number

E1560

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

K931338,K931338

Product Code

HGI

Product Code Name

ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)

Public Device Record Key

cf379364-bedc-448d-8bb7-fe00d4bd20c3

Public Version Date

February 01, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

20884524000234

Quantity per Package

10

Contains DI Package

10884524000237

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE