Catalog Number

FM3001

Brand Name

FMsealer

Version/Model Number

3001

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"

Yes

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

dc8fc200-c90c-4f11-bedd-8f3ab99ee3fc

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 15, 2016

Package DI Number

20859729006152

Quantity per Package

5

Contains DI Package

10859729006155

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box