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

DSPS® Cradle-S H MR - 08719425700441 Catalog Number : 112930

Device Description : DSPS Cradle Type-S, High, MR safe

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

DSPS® Cradle-B H MR - 08719425700458 Catalog Number : 112950

Device Description : DSPS Cradle Type-B, High, MR safe

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Prone Tool Set - 08719425700465 Catalog Number : 112650

Device Description : Prone Tool Set for Mouldroom, including prone tool, reference tool and 5 cushion Prone Tool Set for Mouldroom, including prone tool, reference tool and 5 cushions for head positioning

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

MaxSupport™ 1 - 08719425700748 Catalog Number : 117110

Device Description : MaxSupport™ 1, wide, universal

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

MaxSupport™ 2 - 08719425700755 Catalog Number : 117120

Device Description : MaxSupport 2, red, neutral position

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

MaxSupport™ 3 - 08719425700762 Catalog Number : 117130

Device Description : MaxSupport 3, yellow, chin up

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

MaxSupport™ 4 - 08719425700779 Catalog Number : 117140

Device Description : MaxSupport 4, white, chin up ext

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

MaxSupport™ 5 - 08719425700793 Catalog Number : 117150

Device Description : MaxSupport 5, wideshaped, red, neutral position

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

MaxSupport™ 6 - 08719425700809 Catalog Number : 117160

Device Description : MaxSupport 6, wideshaped, yellow, chin up

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

MaxSupport™ 7 - 08719425700816 Catalog Number : 117170

Device Description : MaxSupport 7, wideshaped, black, chin up ext

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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