SoundBite® Console

GUDID 17540265103028

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.

Soundbite Medical Solutions Inc

Mechanical atherectomy system generator, mechanical output

• Primary Device ID: 17540265103028
• NIH Device Record Key: b33bddab-abc1-43ee-baa5-205963682a40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SoundBite® Console
• Version Model Number: 9AB-C001091
• Company DUNS: 208993667
• Company Name: Soundbite Medical Solutions Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-833-312-9181
• Email: dominique.abecassis@soundbitemedical.com
• Phone: 1-833-312-9181
• Email: dominique.abecassis@soundbitemedical.com
• Phone: 1-833-312-9181
• Email: dominique.abecassis@soundbitemedical.com
• Phone: 1-833-312-9181
• Email: dominique.abecassis@soundbitemedical.com
• Phone: 1-833-312-9181
• Email: dominique.abecassis@soundbitemedical.com
• Phone: 1-833-312-9181
• Email: dominique.abecassis@soundbitemedical.com
• Phone: 1-833-312-9181
• Email: dominique.abecassis@soundbitemedical.com
• Phone: 1-833-312-9181
• Email: dominique.abecassis@soundbitemedical.com
• Phone: 1-833-312-9181
• Email: dominique.abecassis@soundbitemedical.com
• Phone: 1-833-312-9181
• Email: dominique.abecassis@soundbitemedical.com
• Phone: 1-833-312-9181
• Email: dominique.abecassis@soundbitemedical.com
• Phone: 1-833-312-9181
• Email: dominique.abecassis@soundbitemedical.com

Device Dimensions

• Weight: 80 Kilogram
• Width: 13 Inch
• Height: 42 Inch
• Depth: 22 Inch
• Weight: 80 Kilogram
• Width: 13 Inch
• Height: 42 Inch
• Depth: 22 Inch
• Weight: 80 Kilogram
• Width: 13 Inch
• Height: 42 Inch
• Depth: 22 Inch
• Weight: 80 Kilogram
• Width: 13 Inch
• Height: 42 Inch
• Depth: 22 Inch
• Weight: 80 Kilogram
• Width: 13 Inch
• Height: 42 Inch
• Depth: 22 Inch
• Weight: 80 Kilogram
• Width: 13 Inch
• Height: 42 Inch
• Depth: 22 Inch
• Weight: 80 Kilogram
• Width: 13 Inch
• Height: 42 Inch
• Depth: 22 Inch
• Weight: 80 Kilogram
• Width: 13 Inch
• Height: 42 Inch
• Depth: 22 Inch
• Weight: 80 Kilogram
• Width: 13 Inch
• Height: 42 Inch
• Depth: 22 Inch
• Weight: 80 Kilogram
• Width: 13 Inch
• Height: 42 Inch
• Depth: 22 Inch
• Weight: 80 Kilogram
• Width: 13 Inch
• Height: 42 Inch
• Depth: 22 Inch
• Weight: 80 Kilogram
• Width: 13 Inch
• Height: 42 Inch
• Depth: 22 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	17540265103028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210839

FDA Product Code

• PDU: Catheter For Crossing Total Occlusions

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-08
• Device Publish Date: 2021-06-30

On-Brand Devices [SoundBite® Console]

• 10754026503027: The SoundBite® Console generates controlled high-amplitude short-duration mechanical pulses (i.
• 17540265103028: The SoundBite® Console generates controlled high-amplitude short-duration mechanical pulses (i.