Catalog Number

FPRPR3258

Brand Name

IceSphere® 1.5 Cryoablation Needle

Version/Model Number

FPRPR3258

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 25, 2020

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

Product Code

GEH

Product Code Name

Unit, Cryosurgical, Accessories

Public Device Record Key

3fa0d1f3-bf61-4397-9cee-ce01f47df2ff

Public Version Date

September 03, 2021

Public Version Number

7

DI Record Publish Date

August 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-