AccessGUDID - DEVICE: MicroThermX Microwave Ablation System (00851551005002)

GUDID

Device Identifier (DI) Information

Brand Name: MicroThermX Microwave Ablation System
Version or Model: MTX-180
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MTX-180
Company Name: PERSEON CORPORATION

Primary DI Number: 00851551005002
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080414615 *Terms of Use

Device Description: MicroThermX Microwave Ablation System - Mobile Cart

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
61287	Microwave ablation system generator	A mains electricity (AC-powered) device intended to generate microwave energy for localized non-vascular soft-tissue ablation, typically to treat tumours, hydatid cysts and/or menorrhagia. The generator connects via a delivery cable to a probe (not included) for delivery of microwaves to the target tissues. It is intended to be used in percutaneous, laparoscopic, natural orifice or open surgery procedures to ablate tissue typically in the liver, lung, pancreas, kidney, and uterus (e.g., endometrial ablation).	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 [?]
K141785	000

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
Handling Environment Humidity: between 15 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between -15 and 40 Degrees Celsius
Storage Environment Humidity: between 15 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between -15 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6494b1b0-6119-4e5e-9425-ead150cf45bc
Public Version Date: October 18, 2023
Public Version Number: 4
DI Record Publish Date: August 19, 2017