Catalog Number

F5330

Brand Name

NA

Version/Model Number

F5330

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

4015e71e-2c2b-4342-ac07-5f39a3317363

Public Version Date

October 18, 2019

Public Version Number

5

DI Record Publish Date

September 12, 2016

Package DI Number

03700393300585

Quantity per Package

5

Contains DI Package

03700393300127

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box