SoundBite® Curving Tool 14

GUDID 17540265105022

The SoundBite® Curving Tool 14 is used by the Physician to curve the tip of the active wire if desired. Its use is explained in the IFU.

Soundbite Medical Solutions Inc

Surgical probe/cannula bending tool

• Primary Device ID: 17540265105022
• NIH Device Record Key: bfd220b7-3f2b-453a-b82c-fd28622409d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SoundBite® Curving Tool 14
• Version Model Number: 900-0001291
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	17540265105022 [Primary]
GS1	27540265205026 [Package]; Package: Box [5 Units]; In Commercial Distribution
GS1	37540265305020 [Package]; Contains: 27540265205026; Package: Box [10 Units]; In Commercial Distribution

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: true

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® Curving Tool 14]

• 10754026505021: The SoundBite® Curving Tool 14 is used by the Physician to curve the tip of the active wire if
• 17540265105022: The SoundBite® Curving Tool 14 is used by the Physician to curve the tip of the active wire if