MACROMEDICS B.V.

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

S-Type baseplate - 08719425700021 Catalog Number : 111400

Device Description : S-Type baseplate, 2P

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

S-Type baseplate, MR - 08719425700038 Catalog Number : 111450

Device Description : S-Type baseplate, MR safe, 2P

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

SSPS™ Cradle S-Type - 08719425700137 Catalog Number : 111520

Device Description : SSPS cradle standard for SSPS S-Type baseplate

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

DSPS® Cradle-MEXF H - 08719425700236 Catalog Number : 112710

Device Description : DSPS® Cradle Type MacroMedics® ExaFix, high

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

DSPS® Cradle-O H - 08719425700250 Catalog Number : 112720

Device Description : DSPS Cradle Type-O, High

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

DSPS® Cradle-S H MR - 08719425700267 Catalog Number : 112730

Device Description : DSPS Cradle Type-S, High

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

DSPS® Cradle-VRT H - 08719425700274 Catalog Number : 112740

Device Description : DSPS Cradle Type-VRT, High

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

DSPS® Cradle-B H - 08719425700281 Catalog Number : 112750

Device Description : DSPS Cradle Type-B, High

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

DSPS® Cradle-MEXF H MR - 08719425700410 Catalog Number : 112910

Device Description : DSPS® Cradle MacroMedics® ExaFix, high, MR safe

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

DSPS® Cradle-O H MR - 08719425700434 Catalog Number : 112920

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

Device Class : 2

Duns Number: 489730120

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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