Catalog Number

A000925-6

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

Product Code

GEH

Product Code Name

Unit, Cryosurgical, Accessories

Public Device Record Key

30ebfcfe-ff5f-4629-be6c-8fdba916ea60

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

March 18, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-