Ultrasonix Medical Corporation

Basic Information

• Brand Name: Ultrasonix Medical Corporation
• Primary DI: 08294360350536
• Version / Model: 00.035.053
• Company Name: ANALOGIC CORPORATION
• Labeler DUNS: 019677418
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-17
• Public Version: 3
• Public Version Date: 2020-08-27
• Public Version Status: Update
• Public Device Record Key: 6cd0bc30-b7d9-4535-878d-bc1d8a70656e
• Distribution End Date: 2019-08-01

Device Description

BPC8-4/10 Microconvex BPL9-5/55 Linear Biplane Transducer

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	892.1570	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	08294360350536	GS1

Customer Contacts

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