Catalog Number

FPRPR3261

Brand Name

IceSphere® Cryoablation Needle

Version/Model Number

FPRPR3261

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 19, 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

44ef172b-c0a3-4da5-9603-1361c6ab0065

Public Version Date

September 03, 2021

Public Version Number

6

DI Record Publish Date

February 15, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-