SONOPRO

Basic Information

• Brand Name: SONOPRO
• Primary DI: 00860009496903
• Version / Model: 0002
• Catalog Number: SONO-0002
• Company Name: Restec Solutions LLC
• Labeler DUNS: 038833403
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-31
• Public Version: 1
• Public Version Date: 2023-04-10
• Public Version Status: New
• Public Device Record Key: 16411e7e-7d6a-4e52-ac2a-bfe2d2e8e0b5

Device Description

SONOPRO is a limited pre-production run of Automated Disinfector Devices. It is classified by the FDA as a Class II medical device, product code MEC. It is intended for use in the critical care areas of the hospital clinical setting, disinfecting Spaulding category low-risk hand-held re-useable medical devices. Devices must be first pre-cleaned or free of visible bioburden.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• 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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MEC	Disinfector, Medical Devices	General Hospital	880.6992	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66654	Atomized-chemical device disinfector	An electrically-powered unit designed for the disinfection of devices at the point-of-use using ultrasonically generated ultra-fine particle aerosolized disinfectant. It consists of a cabinet with internal shelves intended to accept pre-cleaned medical devices/equipment (including electrical devices), an ultrasonic disinfectant atomizer and a control panel. It is intended to be used as an alternative to wipe down disinfection, and is not intended for use in a reprocessing suite.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860009496903	GS1

Customer Contacts

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