MIRA

Basic Information

• Brand Name: MIRA
• Primary DI: 00850038042097
• Version / Model: 180-130000-100
• Catalog Number: MIRA-SUD-NLP
• 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: e5714da7-9921-4b31-8d54-9676f50e39b4

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
63564	Endoscope sheath, single-use	A component of a rigid or flexible endoscope assembly designed as a tube through which an endoscope (e.g., hysteroscope) and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit; it is also designed to function as a protective barrier to isolate the endoscope from patient contact and prevent contamination of the endoscope controls during a procedure. It typically contains ports to enable the insertion of instruments (through the endoscope or through independent working channels), insufflation ports, valves and connectors. It is made of plastic and metal materials. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850038042097	GS1

Premarket Submissions

Submission Number	Supplement Number
DEN230025	000