Remidio

Basic Information

• Brand Name: Remidio
• Primary DI: 08906096520038
• Version / Model: MRD-10
• Catalog Number: 650711448
• Company Name: REMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITED
• Labeler DUNS: 650711448
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-11-26
• Public Version: 2
• Public Version Date: 2023-07-14
• Public Version Status: Update
• Public Device Record Key: 2c9ffbd2-201b-46c4-8134-0f5ed0469c85

Device Description

Remidio Microscope Recording device MRD-10 is a device attached to a surgical microscope & is used for the video recording of the surgeries related to the eye with an inherent simplicity built in its operation & use.MRD-10 device enables 4k resolution and 60FPS recording using high-resolution optics & i Phone.

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
60492	Surgical microscope video camera, non-sterilizable	A non-sterile optical device intended to be used as part of a video camera surgical microscope system to send magnified images of a surgical site, via a camera and appropriate hardware, to a monitor to facilitate visualization of the surgical site by the surgeon or for teaching applications.. It is typically a housing containing a distal lens, fibreoptic cabling, and an illumination port. It is intended to be fixed (using a positioning arm) at an appropriate distance from the surgical site (e.g., 25-75cm), and is not intended to contact the patient. This is a reusable device after appropriate cleaning.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08906096520038	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity