Medisono

Basic Information

• Brand Name: Medisono
• Primary DI: B369MUS05164
• Version / Model: ENDOCAVITY ARRAY PROBE MODEL MODEL: 6V7 FOR MEDISONO P25 EXPERT
• Catalog Number: MUS05164
• Company Name: Medisono, LLC
• Labeler DUNS: 079686615
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-28
• Public Version: 2
• Public Version Date: 2021-12-22
• Public Version Status: Update
• Public Device Record Key: cf631ff5-4b3d-4470-a5ff-3b08524a93af

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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYN	System, imaging, pulsed doppler, ultrasonic	Radiology	892.1550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40771	Rectal/vaginal ultrasound imaging transducer	An invasive component of an ultrasound imaging assembly designed to be positioned within the vagina and/or rectum, either manually or under endoscopic guidance, for ultrasound imaging from within the vagina/rectum. Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to another device for display; it does not include an integrated display. It may be intended for wired or wireless data transfer and may be intended for use with a dedicated ultrasound system or with an off-the-shelf device (e.g., smartphone) with dedicated software installed. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B369MUS05164	HIBCC

Customer Contacts

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