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 - 07340048301084 Catalog Number :

Device Description : TABLE FIXATION FOR X-RAY, WIDTH 228 MM

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048301091 Catalog Number :

Device Description : TABLE FIX X-RAY, FLAT 240/260

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048301107 Catalog Number :

Device Description : TABLE FIX X-RAY, FLAT 500 MM

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048301114 Catalog Number :

Device Description : TABLE FIX X-RAY, FLAT 550 MM

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048301138 Catalog Number :

Device Description : TABLE FIX X-RAY, SIEMENS CURV

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System Neurosurgical Instruments - 07340048301145 Catalog Number :

Device Description : SALCMAN TWIST DRILL KIT I

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048301152 Catalog Number :

Device Description : OPEN CT INDICATOR

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System Neurosurgical Instruments - 07340048301220 Catalog Number :

Device Description : BACKLUND HAEMATOMA EVACUATOR KIT

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System Neurosurgical Instruments - 07340048301305 Catalog Number :

Device Description : BACKLUND CATHETER INSERTION NEEDLE KIT III

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048301763 Catalog Number :

Device Description : FIXATION SCREW L=25 DISPOSABLE

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

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