IcePearl™ 2.1 CX L 90° Cryoablation Needle - 2.1 mm 90 degree Cryoablation Needle - GALIL MEDICAL LTD

Duns Number:531854560

Device Description: 2.1 mm 90 degree Cryoablation Needle

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More Product Details

Catalog Number

FPRPR3617

Brand Name

IcePearl™ 2.1 CX L 90° Cryoablation Needle

Version/Model Number

FPRPR3617

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

GEH

Product Code Name

Unit, Cryosurgical, Accessories

Device Record Status

Public Device Record Key

9d13126b-985c-455c-b9ac-bdf8b3377f74

Public Version Date

February 04, 2022

Public Version Number

6

DI Record Publish Date

October 14, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GALIL MEDICAL LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 47