MACROMEDICS B.V.

Address:Oostbaan 670,Moordrecht Zuid-Holland,NL

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Filters

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

Accelerator, Linear, Medical (IYE) (10)

Premarket Exempt

No Yes

Clear

MaxSupport™ 25 CF - 08719425700830 Catalog Number : 117125

Device Description : MaxSupport 25, carbon fiber, red, neutral position

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

MaxSupport™ 35 CF - 08719425700847 Catalog Number : 117135

Device Description : MaxSupport 35, carbon fiber, yellow, chin up

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

MaxSupport™ 45 CF - 08719425700854 Catalog Number : 117145

Device Description : MaxSupport 45, carbon fiber, white, chin up ext

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Block high CF ExaFix™ - 08719425700915 Catalog Number : 110520

Device Description : Carbon fiber elevation block, fit for ExaFix, high

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Block low CF ExaFix™ - 08719425700922 Catalog Number : 110510

Device Description : Carbon fiber elevation block, fit for ExaFix, low

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Wedge 7 CF ExaFix™ - 08719425700939 Catalog Number : 110540

Device Description : Carbon fiber wedge, fit for ExaFix, 7 degrees (for hyper extension)

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Wedge 5 CF ExaFix™ - 08719425700946 Catalog Number : 110530

Device Description : Carbon fiber wedge, fit for ExaFix, 5 degrees

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Wedge 10 CF ExaFix™ - 08719425700953 Catalog Number : 110550

Device Description : Carbon fiber wedge, fit for ExaFix,10 degrees

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Wedge 15 CF ExaFix™ - 08719425700960 Catalog Number : 110560

Device Description : Carbon fiber wedge, fit for ExaFix,15 degrees

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Adaptor MaxSupport™ TO - 08719425700991 Catalog Number : 110600

Device Description : Adaptor to fit MacroMedics® head support on Orfit baseplates

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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