Catalog Number

FM2301

Brand Name

FMwand

Version/Model Number

2301

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

K130606,K130606,K130606

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

a24516ae-7ab1-4064-a599-22e646ef3a89

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 09, 2016

Package DI Number

20859729006084

Quantity per Package

5

Contains DI Package

10859729006087

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box