AMERICAN MEDICAL SYSTEMS

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) (10)

Premarket Exempt

No Yes

Clear

AddStat - 00878953000015 Catalog Number :

Device Class : 2

Duns Number: 796308653

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

EndoStat - 00878953000046 Catalog Number :

Device Description : 0.2mm 12ft

Device Class : 2

Duns Number: 796308653

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

EndoStat - 00878953000053 Catalog Number :

Device Description : 0.2mm 12ft SL

Device Class : 2

Duns Number: 796308653

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

EndoStat - 00878953000060 Catalog Number :

Device Description : 0.3mm 12ft

Device Class : 2

Duns Number: 796308653

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

EndoStat - 00878953000077 Catalog Number :

Device Description : 0.6mm 12ft

Device Class : 2

Duns Number: 796308653

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

EndoStat - 00878953000084 Catalog Number :

Device Description : 0.6mm 18ft

Device Class : 2

Duns Number: 796308653

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

EndoStat - 00878953000091 Catalog Number :

Device Description : 0.6mm 12ft

Device Class : 2

Duns Number: 796308653

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

EndoStat - 00878953000107 Catalog Number :

Device Description : 0.4mm 12ft

Device Class : 2

Duns Number: 796308653

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

AccuStat - 00878953000114 Catalog Number :

Device Description : 100um Fiber

Device Class : 2

Duns Number: 796308653

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

AccuStat - 00878953000121 Catalog Number :

Device Description : 125um Fiber

Device Class : 2

Duns Number: 796308653

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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