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 - 07340048300087 Catalog Number :

Device Description : COUNTER SCALE

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048300094 Catalog Number :

Device Description : FRAME FIXATION

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048300100 Catalog Number :

Device Description : LEKSELL STEREOTACTIC SYSTEM CLAMP

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048300124 Catalog Number :

Device Description : FIXATION SCREW KIT, TITANIUM, 20 PAIRS

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048300131 Catalog Number :

Device Description : TITANIUM FIXATION SCREW, KIT 5 PAIRS

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048300148 Catalog Number :

Device Description : REUSABLE FIXATION SCREW, KIT 20 PAIR

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048300155 Catalog Number :

Device Description : REUSABLE FIXATION SCREW, KIT 5 PAIRS

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048300162 Catalog Number :

Device Description : DISPOSABLE QUICK FIXATION SCREWS, 13 PAIRS

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048300209 Catalog Number :

Device Description : TARGET SIMULATOR

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048300216 Catalog Number : 1000351

Device Description : NEEDLE TESTER

Device Class :

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

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