Catalog Number

-

Brand Name

Barrx

Version/Model Number

90-9500

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

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

K093008,K093008

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

b7ea11b1-de1a-4257-b805-db0b135c55e4

Public Version Date

January 26, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

20884521189390

Quantity per Package

5

Contains DI Package

10884521189393

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE