Catalog Number

A000925

Brand Name

AtriCure cryoICE Cryoablation System (CRYO3)

Version/Model Number

CRYO3

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"

Yes

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

K180137,K180137,K180137,K180137

Product Code

GEH

Product Code Name

Unit, Cryosurgical, Accessories

Public Device Record Key

066b8614-948f-4835-b6bb-8a05b4d1c4cd

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

January 08, 2021

Package DI Number

30840143902769

Quantity per Package

1

Contains DI Package

10840143902420

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box