Catalog Number

-

Brand Name

ACMI USA Elite System and USA Series Roller Ball Electrode 28 FR (9.3

Version/Model Number

RE-28

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

K890328,K890328

Product Code

FAS

Product Code Name

ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Public Device Record Key

5a16355b-7b4c-4455-9323-9f4ecc959217

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 05, 2016

Package DI Number

00821925007659

Quantity per Package

6

Contains DI Package

00821925041813

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-