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) (10)

Premarket Exempt

Clear

Leksell Stereotactic System - 07340048300223 Catalog Number :

Device Description : OPEN MR INDICATOR

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048300230 Catalog Number :

Device Description : MR INDICATOR

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048300247 Catalog Number :

Device Description : MR PHANTOM

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System Neurosurgical Instruments - 07340048300285 Catalog Number :

Device Description : BACKLUND CATHETER INSERTION NEEDLE KIT I

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System Neurosurgical Instruments - 07340048300315 Catalog Number :

Device Description : INSERTION CANNULA KIT

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System Neurosurgical Instruments - 07340048300322 Catalog Number :

Device Description : SEDAN SIDE-CUTTING BIOPSY NEEDLE KIT I

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System Neurosurgical Instruments - 07340048300346 Catalog Number :

Device Description : DISPOSABLE BIOPSY NEEDLE 6 KIT

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048300360 Catalog Number :

Device Description : A-P CROSS HAIRS HOLDER

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048300377 Catalog Number :

Device Description : CROSS HAIR TARGET, STAINLESS STEEL

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048300469 Catalog Number :

Device Description : MR-ADAPTER GE SIGNA 1.5T

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

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