AccessGUDID - DEVICE: HEATfx Cart (00859019006400)

GUDID

Device Identifier (DI) Information

Brand Name: HEATfx Cart
Version or Model: FPRCH9010
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: FPRCH9010
Company Name: GALIL MEDICAL INC.

Primary DI Number: 00859019006400
Issuing Agency: GS1
Commercial Distribution End Date: August 14, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 809529469 *Terms of Use

Device Description: Microwave Ablation System Accessory

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
40596	Electromechanical device/system transport trolley	A mobile (on wheels) cart intended to be used as a carrier for transporting an electromechanical device(s) or a powered system assembly. This trolley (cart) may be designed specifically for a proprietary control unit/system, and will typically have one or more horizontal surfaces where the devices are placed; it may include additional features (e.g., gas cylinder holder, intravenous pole) specific to a proprietary system. Neither electromechanical devices nor system components are included.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NEY	System, Ablation, Microwave And Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

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