Catalog Number

RFDE-VA-1

Brand Name

RFDE-VA

Version/Model Number

RFDE-VA

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

K130689,K130689

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

673e8710-a4a8-4a22-9a7b-3035edad5c99

Public Version Date

April 11, 2022

Public Version Number

6

DI Record Publish Date

September 23, 2016

Package DI Number

10817371020097

Quantity per Package

5

Contains DI Package

00817371020052

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box