AccessGUDID - DEVICE: HEATfx 2.1 15cm Needle (07290104831157)

GUDID

Device Identifier (DI) Information

Brand Name: HEATfx 2.1 15cm Needle
Version or Model: FPRPR5102
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: FPRPR5102
Company Name: GALIL MEDICAL INC.

Primary DI Number: 07290104831157
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 needle

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:	Yes
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?
61286	Microwave ablation system probe, non-powered	A non-active, hand-held surgical instrument designed to connect to a microwave ablation system generator to deliver microwaves to a targeted operative site for localized soft-tissue ablation, typically to treat tumours, hydatid cysts and/or menorrhagia. The probe includes a handle and a patient contact region (e.g., antenna, leaflets), and might include a cooling mechanism (via water irrigation). The device is intended to be used in percutaneous, endoscopic [e.g., gastroscopic, laparoscopic], natural orifice or open surgery procedures to ablate tissues (e.g., endometrial ablation). This is a single-use device.	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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Cool, dry place

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Shaft diameter: 2.1mm
Device Size Text, specify: Shaft Length: 15cm

Device Record Status

Public Device Record Key: b2e76b8f-0db3-487e-9f48-654d31bf6d27
Public Version Date: October 18, 2023
Public Version Number: 4
DI Record Publish Date: August 14, 2020