MIRA

Basic Information

• Brand Name: MIRA
• Primary DI: 00850038042011
• Version / Model: 180-010000-000
• Catalog Number: MIRA-REP-CA1
• 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: c338f312-c30a-4b23-aae0-cc10049decd4

Device Characteristics

• Single Use: No
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Hydrogen Peroxide

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
32259	Endoscope cine camera	An electro-optical device that is designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to obtain moving-picture documentation of endoscopic findings and procedures. It typically consists of a lightproof chamber with an aperture fitted with a lens and a shutter, through which the image of an object is projected onto a surface for recording. It records a sequence of photographs and usually projects them sequentially to obtain a motion picture. The device may also include audio recording capabilities.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850038042011	GS1

Premarket Submissions

Submission Number	Supplement Number
DEN230025	000