Soundbite Medical Solutions Inc

Address:2300 Boulevard Alfred-Nobel,Montreal Quebec,CA

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Device Description : The SoundBite® Active Wire 14P which is part of the SoundBite® Crossing System The SoundBite® Active Wire 14P which is part of the SoundBite® Crossing System - Peripheral (14P) is supplied sterile, has a maximum outer diameter of 0.014” in its usable length (145 cm) and is 300 cm long. Only the distal 145 cm of the SoundBite® Active Wire 14P is ever in contact with patient vasculature. At the proximal end of the SoundBite® Active Wire 14P, a section reducer allows the wire to be connected to the SoundBite® Console.

Device Class :

Duns Number: 208993667

Premarket Exempt : No

Product Code : PDU

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The SoundBite® Console generates controlled high-amplitude short-duration mechan 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 Class : 2

Duns Number: 208993667

Premarket Exempt : No

Product Code : PDU

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The SoundBite® Curving Tool 14 is used by the Physician to curve the tip of the 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.

Device Class :

Duns Number: 208993667

Premarket Exempt : No

Product Code : PDU

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The SoundBite® Active Wire 14P which is part of the SoundBite® Crossing System The SoundBite® Active Wire 14P which is part of the SoundBite® Crossing System - Peripheral (14P) is supplied sterile, has a maximum outer diameter of 0.014” in its usable length (145 cm) and is 300 cm long. Only the distal 145 cm of the SoundBite® Active Wire 14P is ever in contact with patient vasculature. At the proximal end of the SoundBite® Active Wire 14P, a section reducer allows the wire to be connected to the SoundBite® Console.

Device Class : 2

Duns Number: 208993667

Premarket Exempt : No

Product Code : PDU

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The SoundBite® Console generates controlled high-amplitude short-duration mechan 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 Class : 2

Duns Number: 208993667

Premarket Exempt : No

Product Code : PDU

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The SoundBite® Curving Tool 14 is used by the Physician to curve the tip of the 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.

Device Class :

Duns Number: 208993667

Premarket Exempt : No

Product Code : PDU

Prescription Use : Yes

Device Count : 1