Catalog Number

FM2121

Brand Name

FMwand

Version/Model Number

2121

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 22, 2016

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

e2c877c7-9b48-4491-b7eb-7ec29cc0e1bf

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 10, 2016

Package DI Number

20859729006077

Quantity per Package

5

Contains DI Package

10859729006070

Package Discontinue Date

September 22, 2016

Package Status

Not in Commercial Distribution

Package Type

Box