AMERICAN MEDICAL SYSTEMS

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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

Powered Laser Surgical Instrument (GEX) (8) Accessories, Photographic, For Endoscope (Exclude Light Sources) (FEM) (1)

Premarket Exempt

No Yes

Clear

SureFlex 200 - 00878953004822 Catalog Number :

Device Description : 200 Lithotripsy Fiber

Device Class : 2

Duns Number: 796308653

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

GreenLight XPS - 00878953005508 Catalog Number :

Device Description : Laser System

Device Class : 2

Duns Number: 796308653

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

GreenLight XPS - 00878953007625 Catalog Number :

Device Description : Laser System

Device Class : 2

Duns Number: 796308653

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Video Camera Insert - 00878953007656 Catalog Number :

Device Description : Video Camera Insert/Filter For Rigid Endoscope

Device Class : 1

Duns Number: 796308653

Premarket Exempt : Yes

Product Code : FEM

Prescription Use : Yes

Device Count : 1

NA - 00878953007670 Catalog Number :

Device Description : Microstat Bayonet, 6 cm

Device Class : 2

Duns Number: 796308653

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

XPS and HPS - 00878953009346 Catalog Number :

Device Description : Footswitch

Device Class : 2

Duns Number: 796308653

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Aura XP - 00878953009353 Catalog Number :

Device Description : Footswitch

Device Class : 2

Duns Number: 796308653

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Aura XP - 00878953009360 Catalog Number :

Device Description : International Power Cable

Device Class : 2

Duns Number: 796308653

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Aura XP - 00878953009377 Catalog Number :

Device Description : US Power Cable

Device Class : 2

Duns Number: 796308653

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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