Catalog Number

A000835

Brand Name

AtriCure System Cart

Version/Model Number

ASCS

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

HMF

Product Code Name

Stand, Instrument, Ac-Powered, Ophthalmic

Public Device Record Key

4e6a8bbc-51bd-4418-a496-d39ca8baa4ac

Public Version Date

January 19, 2021

Public Version Number

1

DI Record Publish Date

January 11, 2021

Package DI Number

30840143903124

Quantity per Package

1

Contains DI Package

10840143901515

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box