MIRA

Basic Information

• Brand Name: MIRA
• Primary DI: 00850038042066
• Version / Model: 180-050000-102
• Catalog Number: MIRA-SUD-MPS
• Company Name: Virtual Incision Corporation
• Labeler DUNS: 041508596
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-24
• Public Version: 1
• Public Version Date: 2024-07-02
• Public Version Status: New
• Public Device Record Key: feba0ab0-7c31-4778-a5c2-9f9a6c138c1f

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
SAB	Table Mounted Miniaturized Electromechanical Surgical System	General, Plastic Surgery	878.4962	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65882	Robotic electrosurgical instrument, bipolar/monopolar	An electrosurgical device intended to be connected directly to the arm of a robotic surgical system to deliver electrosurgical current in both a bipolar and monopolar configuration from a generator directly to tissues for cutting/coagulation/ablation during robotic endoscopic (e.g., laparoscopic, arthroscopic) surgery. It includes a long thin body with a proximal housing intended to attach to the robotic arm, and includes the distal bipolar/monopolar electrodes in a variety of forms (e.g., forceps, hook, tip). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850038042066	GS1

Premarket Submissions

Submission Number	Supplement Number
DEN230025	000