Catalog Number

3421

Brand Name

ReNew

Version/Model Number

3421

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

-

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

300072bd-5f00-4573-a058-7ddc44f4242a

Public Version Date

August 21, 2019

Public Version Number

3

DI Record Publish Date

November 13, 2017

Package DI Number

00811099011033

Quantity per Package

5

Contains DI Package

00811099011835

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box