Elekta Instrument AB

Address:Kungstensgatan 18,Stockholm,SE

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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

Neurological stereotaxic Instrument (HAW) (6) Neurological Stereotaxic Instrument (HAW) (4)

Premarket Exempt

Clear

Leksell Stereotactic System Neurosurgical Instruments - 07340048311380 Catalog Number :

Device Description : NEEDLE WITH LUER LOCK

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048311403 Catalog Number : 1006472

Device Description : INSTRUMENT SCREWDRIVER, DOUBLE

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Vantage Stereotactic System - 07340048311410 Catalog Number : 1072447

Device Description : LEKSELL VANTAGE FRAME HOLDER

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Vantage Stereotactic System - 07340048311427 Catalog Number : 1072928

Device Description : LEKSELL VANTAGE CT FIDUCIAL BOX

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Vantage Stereotactic System - 07340048311441 Catalog Number : 1072922

Device Description : Vantage™ Frame Holder extension

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Vantage Stereotactic System - 07340048311465 Catalog Number : 1072893

Device Description : LEKSELL VANTAGE CT INTERFACE

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048311526 Catalog Number : 1013578

Device Description : STERILIZING TRAY FOR G FRAME KIT

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048311533 Catalog Number : 1001015

Device Description : STERILIZING TRAY FOR NEEDLE TESTER

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048311540 Catalog Number : 917171

Device Description : STERILIZING CASE FIXATION SCREWS

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048311557 Catalog Number : 60082-05

Device Description : STERILIZING TRAY / SMALL

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

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