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

Adaptor MaxSupport™ TS - 08719425701004 Catalog Number : 110650

Device Description : Carbon fiber adaptor plate to fit MaxSupports on Type-S

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Pron Pillo - 08719425701059 Catalog Number : 116800

Device Description : Pron Pillo

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Pron Pillo, Indexable - 08719425701066 Catalog Number : 116850

Device Description : Indexable Pron Pillo for the Pelvic Prone Board

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

MaxSupport™ Prone - 08719425701073 Catalog Number : 116940

Device Description : MaxSupport Prone

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

MaxSupport™ PedSupine - 08719425701080 Catalog Number : 116950

Device Description : MaxSupport Pediatric Supine

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BreastBoardLX™ - 08719425702056 Catalog Number : 122500

Device Description : BreastBoard LX™, 2P, extended cushion aperture, adjustable lower arm supports wi BreastBoard LX™, 2P, extended cushion aperture, adjustable lower arm supports with high armcup, adjustable cranial arm supports with high armcup, bottomstop, integrated L-profile mask fixation points

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

ThoraxSupport™ - 08719425702070 Catalog Number : 122100

Device Description : ThoraxSupport, 2P, extended cushion aperture, adjustable lower arm supports with ThoraxSupport, 2P, extended cushion aperture, adjustable lower arm supports with high armcup, adjustable cranial arm supports with high armcup, integrated mask fixation points

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

HighBridgeSupp. TS/MBLX - 08719425702148 Catalog Number : 122540

Device Description : High Bridge Support for lowerarms, type for BreastBoard/ThoraxSupport

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BottomStop Adaption - 08719425702155 Catalog Number : 122590

Device Description : Bottomstop adaption to fit on BreastBoard to assist the shorter patient

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

KneeSupport™ - 08719425702285 Catalog Number : 130100

Device Description : KneeSupport coated, 3P

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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