Qfix

Address:440 CHURCH ROAD,Avondale,PA,19311,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Couch, radiation therapy, powered (JAI) (6) Couch, Radiation Therapy, Powered (JAI) (4)

Premarket Exempt

No Yes

Clear

VacQfix™ - 10841962119259 Catalog Number : RT-4517-PB1M

Device Description : VacQfix Cushion, Prone Breast Cushion w/Contralateral Breast Support

Device Class : 2

Duns Number: 808875397

Premarket Exempt : No

Product Code : JAI

Prescription Use : Yes

Device Count : 1

VacQfix™ - 10841962119266 Catalog Number : RT-4517-PB2

Device Description : VacQfix Cushion, Prone Breast Cushion Without Contralateral Breast Support

Device Class : 2

Duns Number: 808875397

Premarket Exempt : No

Product Code : JAI

Prescription Use : Yes

Device Count : 1

VacQfix™ - 10841962119273 Catalog Number : RT-4517-PB2M

Device Description : VacQfix Cushion, Prone Breast Cushion Without Contralateral Breast Support

Device Class : 2

Duns Number: 808875397

Premarket Exempt : No

Product Code : JAI

Prescription Use : Yes

Device Count : 1

VacQfix™ - 10841962119280 Catalog Number : RT-4517-PB3

Device Description : VacQfix Cushion, 96 x 55 cm, 12L Fill

Device Class : 2

Duns Number: 808875397

Premarket Exempt : No

Product Code : JAI

Prescription Use : Yes

Device Count : 1

VacQfix™ - 10841962119297 Catalog Number : RT-4517-PB3M

Device Description : VacQfix Cushion, 96 X 55cm, 12L Fill

Device Class : 2

Duns Number: 808875397

Premarket Exempt : No

Product Code : JAI

Prescription Use : Yes

Device Count : 1

VacQfix™ - 10841962119303 Catalog Number : RT-4517-PB4

Device Description : VacQfix Cushion, 96 x 55 cm, 15L Fill

Device Class : 2

Duns Number: 808875397

Premarket Exempt : No

Product Code : JAI

Prescription Use : Yes

Device Count : 1

VacQfix™ - 10841962119310 Catalog Number : RT-4517-PB4M

Device Description : VacQfix Cushion, 96 X 55cm, 15L Fill

Device Class : 2

Duns Number: 808875397

Premarket Exempt : No

Product Code : JAI

Prescription Use : Yes

Device Count : 1

VacQfix™ - 10841962119327 Catalog Number : RT-4517-T6565F7

Device Description : VacQfix Cushion, 65cm x 65cm, T-Shaped , 7L fill

Device Class : 2

Duns Number: 808875397

Premarket Exempt : No

Product Code : JAI

Prescription Use : Yes

Device Count : 1

VacQfix™ - 10841962119334 Catalog Number : RT-4517-T6565F7M

Device Description : VacQfix Cushion, 65cm x 65cm, T-Shaped, 7L fill

Device Class : 2

Duns Number: 808875397

Premarket Exempt : No

Product Code : JAI

Prescription Use : Yes

Device Count : 1

VacQfix™ - 10841962119341 Catalog Number : RT-4517-T7993F20

Device Description : VacQfix Cushion 79cm x 93cm, 20L fill

Device Class : 2

Duns Number: 808875397

Premarket Exempt : No

Product Code : JAI

Prescription Use : Yes

Device Count : 1

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