HEATfx Cart - Microwave Ablation System Accessory - GALIL MEDICAL INC.

Duns Number:809529469

Device Description: Microwave Ablation System Accessory

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More Product Details

Catalog Number

FPRCH9010

Brand Name

HEATfx Cart

Version/Model Number

FPRCH9010

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 14, 2020

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

-

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

NEY

Product Code Name

System, Ablation, Microwave And Accessories

Device Record Status

Public Device Record Key

ff807781-732f-47f0-ba97-d457ed92fe88

Public Version Date

September 03, 2021

Public Version Number

3

DI Record Publish Date

August 14, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GALIL MEDICAL INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 43