Catalog Number

FPRPR3506

Brand Name

IceEDGE® 2.4 90° Cryoablation Needle

Version/Model Number

FPRPR3506

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

November 03, 2022

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

2541fe29-fed8-4341-87fd-7e65fc78e898

Public Version Date

February 04, 2022

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

-