Catalog Number

-

Brand Name

Barrx

Version/Model Number

32041-31

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 04, 2021

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

K083711

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

1ce5ee94-c40f-4fb5-b869-4f786542c422

Public Version Date

August 26, 2022

Public Version Number

10

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-