MIDAScope™ - 120 and Introducer Kit

Basic Information

• Brand Name: MIDAScope™ - 120 and Introducer Kit
• Primary DI: 00865351000303
• Version / Model: IV-ASY-0600
• Catalog Number: IV-ASY-0600
• Company Name: INTRAVU, INC.
• Labeler DUNS: 116708692
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-18
• Public Version: 3
• Public Version Date: 2023-11-17
• Public Version Status: Update
• Public Device Record Key: a6cf1294-3e6e-4f71-a6de-ff7f93eed7f4
• Distribution End Date: 2019-11-25

Device Description

Kit containing 120mm Scope and 120mm Cannula, 120mm Trocar, and Stopcock. MIDAScope™ is a miniaturized, sterile, single-use disposable scope for use with the MIDASystem™ reusable video processing unit.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	876.1500	2
HRX	Arthroscope	Orthopedic	888.1100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62570	Rigid optical arthroscope, single-use	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the interior of a joint [e.g., knee, shoulder, elbow, temporomandibular joint (TMJ)]. It is inserted into the body through an artificial orifice created by an incision made during arthroscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This device is typically used to examine structural damage to a joint, often from sports injuries. The eyepiece is normally interfaced with a video camera. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00865351000303	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K181982	000

Device Sizes

Type	Value	Unit	Text
Length	120	Millimeter

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -18 – 60 Degrees Celsius