Address:KRAFTGATAN 8,HORBY Skane,SE
Device Description : Provox NID is a non-indwelling voice prosthesis for patients who are capable of Provox NID is a non-indwelling voice prosthesis for patients who are capable of handling the exchange and maintenance of a voice prosthesis independently of a clinician or physician.
Device Class : 2
Duns Number: 355470923
Premarket Exempt : No
Prescription Use : Yes
Device Description : Provox NID is a non-indwelling voice prosthesis for patients who are capable of Provox NID is a non-indwelling voice prosthesis for patients who are capable of handling the exchange and maintenance of a voice prosthesis independently of a clinician or physician.
Device Class : 2
Duns Number: 355470923
Premarket Exempt : No
Prescription Use : Yes
Device Description : Provox ActiValve Lubricant shall be applied as a thin film on the inner lumen of Provox ActiValve Lubricant shall be applied as a thin film on the inner lumen of Provox ActiValve voice prosthesis to help prevent occasional temporary blockage of the valve.
Device Class : 2
Duns Number: 355470923
Premarket Exempt : No
Prescription Use : No
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