Minitouch

Basic Information

• Brand Name: Minitouch
• Primary DI: 00850044503018
• Version / Model: Handpiece 3.8 Era
• Catalog Number: 4501
• Company Name: Microcube, LLC
• Labeler DUNS: 615286320
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-18
• Public Version: 1
• Public Version Date: 2023-10-26
• Public Version Status: New
• Public Device Record Key: 001932b4-2b76-47e2-b96c-30c5f82fa459

Device Description

Minitouch 3.8 Era Handpiece, pouch, sterile

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MNB	Device, Thermal Ablation, Endometrial	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850044503018	GS1

Premarket Submissions

Submission Number	Supplement Number
P230002	000