SoundBite® Console

Basic Information

• Brand Name: SoundBite® Console
• Primary DI: 10754026503027
• Version / Model: 9AB-C001091
• Company Name: Soundbite Medical Solutions Inc
• Labeler DUNS: 208993667
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-30
• Public Version: 3
• Public Version Date: 2021-06-30
• Public Version Status: Update
• Public Device Record Key: a188048a-8e53-479c-8b7b-c43d3928d692
• Distribution End Date: 2021-06-30

Device Description

The SoundBite® Console generates controlled high-amplitude short-duration mechanical pulses (i.e., shock waves) which are transmitted to a connected SoundBite® Active Wire 14P and cause the distal tip of the active wire to move back and forth (axially), acting like a micro-jackhammer. After the passage of each pulse, the tip goes back to its original position.

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: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
PDU	Catheter For Crossing Total Occlusions	Cardiovascular	870.1250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59224	Mechanical atherectomy system generator, mechanical output	A mains electricity (AC-powered) component of a mechanical atherectomy system designed to generate mechanical energy that is typically transmitted through a separate catheter/handpiece for the fragmentation of a chronic partial occlusion (CPO) or chronic total occlusion (CTO) of both coronary and peripheral arteries during an atherectomy procedure. The device may be operated via a remote control or foot-switch and may include an integrated suction/aspiration system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10754026503027	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K210839	000

Device Sizes

Type	Value	Unit	Text
Weight	80	Kilogram
Width	13	Inch
Height	42	Inch
Depth	22	Inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius