Catalog Number

A001012

Brand Name

AtriCure cryoICE cryoSPHERE Cryoablation System

Version/Model Number

CRYOS-L

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

K182565,K200697,K182565,K200697,K182565,K200697,K182565,K200697

Product Code

GXH

Product Code Name

Device, Surgical, Cryogenic

Public Device Record Key

c3b3127b-4767-4f37-a328-38309532ba6e

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

January 08, 2021

Package DI Number

30840143902929

Quantity per Package

1

Contains DI Package

10840143902550

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box