Catalog Number

-

Brand Name

ACMI USA Elite System and USA Series Resec Trode Vaporization Electr

Version/Model Number

VE-RT

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

K973820,K973820

Product Code

FAS

Product Code Name

ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Public Device Record Key

d5e2280a-6dde-4a79-bac8-4cb05e4b147d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 06, 2016

Package DI Number

00821925008120

Quantity per Package

6

Contains DI Package

00821925041837

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-