Address:KRAFTGATAN 8,HORBY Skane,SE
Device Description : The Provox ActiValve voice prosthesis has a one-way valve and two retention flan The Provox ActiValve voice prosthesis has a one-way valve and two retention flanges. A rigid blue ring sits inside the prosthesis, adding stability and providing an even sealing surface for the valve flap. The blue ring and valve flap can be seen on X-ray. Magnets in the ring and valve flap determine the force needed to open the valve (the magnets are not adjustable). Provox ActiValve comes in different opening forces.
Device Class : 2
Duns Number: 355470923
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Provox ActiValve voice prosthesis has a one-way valve and two retention flan The Provox ActiValve voice prosthesis has a one-way valve and two retention flanges. A rigid blue ring sits inside the prosthesis, adding stability and providing an even sealing surface for the valve flap. The blue ring and valve flap can be seen on X-ray. Magnets in the ring and valve flap determine the force needed to open the valve (the magnets are not adjustable). Provox ActiValve comes in different opening forces.
Device Class : 2
Duns Number: 355470923
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Provox ActiValve voice prosthesis has a one-way valve and two retention flan The Provox ActiValve voice prosthesis has a one-way valve and two retention flanges. A rigid blue ring sits inside the prosthesis, adding stability and providing an even sealing surface for the valve flap. The blue ring and valve flap can be seen on X-ray. Magnets in the ring and valve flap determine the force needed to open the valve (the magnets are not adjustable). Provox ActiValve comes in different opening forces.
Device Class : 2
Duns Number: 355470923
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Provox ActiValve voice prosthesis has a one-way valve and two retention flan The Provox ActiValve voice prosthesis has a one-way valve and two retention flanges. A rigid blue ring sits inside the prosthesis, adding stability and providing an even sealing surface for the valve flap. The blue ring and valve flap can be seen on X-ray. Magnets in the ring and valve flap determine the force needed to open the valve (the magnets are not adjustable). Provox ActiValve comes in different opening forces.
Device Class : 2
Duns Number: 355470923
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Provox ActiValve voice prosthesis has a one-way valve and two retention flan The Provox ActiValve voice prosthesis has a one-way valve and two retention flanges. A rigid blue ring sits inside the prosthesis, adding stability and providing an even sealing surface for the valve flap. The blue ring and valve flap can be seen on X-ray. Magnets in the ring and valve flap determine the force needed to open the valve (the magnets are not adjustable). Provox ActiValve comes in different opening forces.
Device Class : 2
Duns Number: 355470923
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Provox ActiValve voice prosthesis has a one-way valve and two retention flan The Provox ActiValve voice prosthesis has a one-way valve and two retention flanges. A rigid blue ring sits inside the prosthesis, adding stability and providing an even sealing surface for the valve flap. The blue ring and valve flap can be seen on X-ray. Magnets in the ring and valve flap determine the force needed to open the valve (the magnets are not adjustable). Provox ActiValve comes in different opening forces.
Device Class : 2
Duns Number: 355470923
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Provox ActiValve voice prosthesis has a one-way valve and two retention flan The Provox ActiValve voice prosthesis has a one-way valve and two retention flanges. A rigid blue ring sits inside the prosthesis, adding stability and providing an even sealing surface for the valve flap. The blue ring and valve flap can be seen on X-ray. Magnets in the ring and valve flap determine the force needed to open the valve (the magnets are not adjustable). Provox ActiValve comes in different opening forces.
Device Class : 2
Duns Number: 355470923
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Provox ActiValve voice prosthesis has a one-way valve and two retention flan The Provox ActiValve voice prosthesis has a one-way valve and two retention flanges. A rigid blue ring sits inside the prosthesis, adding stability and providing an even sealing surface for the valve flap. The blue ring and valve flap can be seen on X-ray. Magnets in the ring and valve flap determine the force needed to open the valve (the magnets are not adjustable). Provox ActiValve comes in different opening forces.
Device Class : 2
Duns Number: 355470923
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Provox Plug is a first-aid tool for temporarily stopping leakage through the The Provox Plug is a first-aid tool for temporarily stopping leakage through the voice prosthesis. The device is inserted into the opening of the Provox voice prosthesis. The medallion end can be taped to the skin if desired.
Device Class : 2
Duns Number: 355470923
Premarket Exempt : No
Prescription Use : No
Device Description : The Provox GuideWire is a sterile, single use insertion device intended for plac The Provox GuideWire is a sterile, single use insertion device intended for placement of a sterile Provox indwelling voice prosthesis after total laryngectomy (primary or secondary puncture), or for retrograde replacement of a sterile Provox indwelling voice prosthesis.
Device Class : 2
Duns Number: 355470923
Premarket Exempt : No
Prescription Use : Yes