Leica Microsystems (Schweiz) AG

Address:MAX SCHMIDHEINY-STRASSE 201,HEERBRUGG Sankt Gallen,CH

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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

MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY (FSO) (7) MICROSCOPE, SURGICAL (EPT) (3)

Premarket Exempt

No Yes

Clear

M620 Optics Carrier - 07630003524475 Catalog Number :

Device Description : M620 Set Optics carrier,focus, tilt - for Leica surgical operating microscope sy M620 Set Optics carrier,focus, tilt - for Leica surgical operating microscope systems: M620 F20, M620 TTS

Device Class : 1

Duns Number: 480198725

Premarket Exempt : Yes

Product Code : FSO

Prescription Use : Yes

Device Count : 1

M620 TTS - 07630003525243 Catalog Number :

Device Description : Table Top System for M620 - for Leica surgical operating microscope system: M620 TTS

Device Class : 1

Duns Number: 480198725

Premarket Exempt : Yes

Product Code : FSO

Prescription Use : Yes

Device Count : 1

M844 Optics Carrier - 07630003525472 Catalog Number :

Device Description : M844 Set Optics carr./focus/XY assistant - for Leica surgical operating microsco M844 Set Optics carr./focus/XY assistant - for Leica surgical operating microscope systems: M844 F20, M844 F40, M844 CT40, M844 C40

Device Class : 1

Duns Number: 480198725

Premarket Exempt : Yes

Product Code : FSO

Prescription Use : Yes

Device Count : 1

M844 F40 / M822 F40 - 07630003526233 Catalog Number :

Device Description : F40 stand for M844/M820 - for Leica surgical operating microscope systems: M844 F40 stand for M844/M820 - for Leica surgical operating microscope systems: M844 F40, M822 F40

Device Class : 1

Duns Number: 480198725

Premarket Exempt : Yes

Product Code : FSO

Prescription Use : Yes

Device Count : 1

M822 C40 / M822 CT40 / M844 C40 / M844 CT40 - 07630003526295 Catalog Number :

Device Description : C40 Ceiling swingarm for M844 / M822 - for Leica surgical operating microscope s C40 Ceiling swingarm for M844 / M822 - for Leica surgical operating microscope systems: M822 C40, M822 CT40, M844 C40, M844 CT40

Device Class : 1

Duns Number: 480198725

Premarket Exempt : Yes

Product Code : FSO

Prescription Use : Yes

Device Count : 1

M525 F20 - 07630003551907 Catalog Number :

Device Description : Floorstand System F20 for M525 - for Leica surgical operating microscope system: M525 F20

Device Class : 1

Duns Number: 480198725

Premarket Exempt : Yes

Product Code : EPT

Prescription Use : Yes

Device Count : 1

M525 Optics Carrier - 07630003551914 Catalog Number :

Device Description : Optics carrier M525 OH4 / F20 / CT20 - for Leica surgical operating microscope s Optics carrier M525 OH4 / F20 / CT20 - for Leica surgical operating microscope systems: M525 F20, M525 CT20

Device Class : 1

Duns Number: 480198725

Premarket Exempt : Yes

Product Code : EPT

Prescription Use : Yes

Device Count : 1

M220 F12 - 07630003552188 Catalog Number :

Device Description : M220 set microscope, stand, footswitch - for Leica surgical operating microscope M220 set microscope, stand, footswitch - for Leica surgical operating microscope system: M220 F12

Device Class : 1

Duns Number: 480198725

Premarket Exempt : Yes

Product Code : FSO

Prescription Use : Yes

Device Count : 1

M620 F20 - 07630003552195 Catalog Number :

Device Description : F20 Stand system for M620 - for Leica surgical operating microscope system: M620 F20

Device Class : 1

Duns Number: 480198725

Premarket Exempt : Yes

Product Code : FSO

Prescription Use : Yes

Device Count : 1

M525 CT20 - 07630003552621 Catalog Number :

Device Description : Swing Stand System M525 CT20 - for Leica surgical operating microscope system: M525 CT20

Device Class : 1

Duns Number: 480198725

Premarket Exempt : Yes

Product Code : EPT

Prescription Use : Yes

Device Count : 1

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