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) (9) System, radiation therapy, radionuclide (IWB) (1)

Premarket Exempt

Clear

Leksell Stereotactic System Neurosurgical Instruments - 07340048308588 Catalog Number :

Device Description : SEDAN CUTTING NEEDLE 2.5 MM

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System Neurosurgical Instruments - 07340048308595 Catalog Number :

Device Description : SEDAN SIDE-CUTTING BIOPSY NEEDLE KIT 2

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System Neurosurgical Instruments - 07340048308601 Catalog Number :

Device Description : SALCMAN TWIST DRILL 2.1/3.2

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System Neurosurgical Instruments - 07340048308618 Catalog Number :

Device Description : CATH. INSERTION NEEDLE / 1.5 MM

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System Neurosurgical Instruments - 07340048308625 Catalog Number :

Device Description : CATHETHER INSERTION NEEDLE / 2.6 MM

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System Neurosurgical Instruments - 07340048308632 Catalog Number :

Device Description : INSERTION CANNULA 190/1.6

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System Neurosurgical Instruments - 07340048308649 Catalog Number :

Device Description : LUER CONNECTION NEEDLE

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System Neurosurgical Instruments - 07340048308656 Catalog Number :

Device Description : HAEMATOMA EVACUATOR 4.0 MM

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Gamma Knife Perfexion/Icon - 07340048309516 Catalog Number :

Device Description : FRAME FIXATION ADAPTER

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : IWB

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048311113 Catalog Number :

Device Description : SKULL SCALING INSTRUMENT

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

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