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 - 07340048301770 Catalog Number :

Device Description : FIXATION SCREW L=30 DISPOSABLE

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048301787 Catalog Number :

Device Description : FIXATION SCREW L=35 DISPOSABLE

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048301794 Catalog Number :

Device Description : FIXATION SCREW L=40 DISPOSABLE

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048301800 Catalog Number :

Device Description : FIXATION SCREW L=45 DISPOSABLE

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048301817 Catalog Number :

Device Description : FIXATION SCREW L=50 DISPOSABLE

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048301824 Catalog Number :

Device Description : FIXATION SCREW L=55 DISPOSABLE

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048301831 Catalog Number :

Device Description : FIXATION SCREW L=60 DISPOSABLE

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048301848 Catalog Number :

Device Description : FIXATION SCREW L=65 DISPOSABLE

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048301855 Catalog Number :

Device Description : FIXATION SCREW L=70 DISPOSABLE

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048301862 Catalog Number :

Device Description : FIXATION SCREW L=75 DISPOSABLE

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

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