AMERICAN MEDICAL SYSTEMS, INC.

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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

Device, Incontinence, Mechanical/Hydraulic (EZY) (7) Prosthesis, Penis, Inflatable (JCW) (4) Device, Impotence, Mechanical/Hydraulic (FHW) (3) Prosthesis, Penile (FAE) (2)

Premarket Exempt

No Yes

Clear

Furlow Insertion Tool - 00878953000176 Catalog Number :

Device Description : Cylinder Insertion Tool

Device Class :

Duns Number: 125111448

Premarket Exempt : No

Product Code : JCW, FHW

Prescription Use : Yes

Device Count : 1

Sizer - 00878953000497 Catalog Number :

Device Description : Cylinder Sizing Tool

Device Class : 2

Duns Number: 125111448

Premarket Exempt : No

Product Code : FAE, FHW, JCW

Prescription Use : Yes

Device Count : 1

Sizer - 00878953000503 Catalog Number :

Device Description : Cylinder Sizing Tool

Device Class : 2

Duns Number: 125111448

Premarket Exempt : No

Product Code : FAE, FHW, JCW

Prescription Use : Yes

Device Count : 1

Insertion Package - 00878953000558 Catalog Number :

Device Description : Tubing Passer

Device Class :

Duns Number: 125111448

Premarket Exempt : No

Product Code : JCW, EZY

Prescription Use : Yes

Device Count : 1

AMS 800 Artificial Urinary Sphincter - 00878953000602 Catalog Number :

Device Description : Pressure Regulating Balloon, Pressure: 41-50 cm H20

Device Class : 3

Duns Number: 125111448

Premarket Exempt : No

Product Code : EZY

Prescription Use : Yes

Device Count : 1

AMS 800 Artificial Urinary Sphincter - 00878953000619 Catalog Number :

Device Description : Pressure Regulating Balloon, Pressure: 51-60 cm H20

Device Class : 3

Duns Number: 125111448

Premarket Exempt : No

Product Code : EZY

Prescription Use : Yes

Device Count : 1

AMS 800 Artificial Urinary Sphincter - 00878953000626 Catalog Number :

Device Description : Pressure Regulating Balloon, Pressure: 61-70 cm H20

Device Class : 3

Duns Number: 125111448

Premarket Exempt : No

Product Code : EZY

Prescription Use : Yes

Device Count : 1

AMS 800 Artificial Urinary Sphincter - 00878953000633 Catalog Number :

Device Description : Pressure Regulating Balloon, Pressure: 71-80 cm H20

Device Class : 3

Duns Number: 125111448

Premarket Exempt : No

Product Code : EZY

Prescription Use : Yes

Device Count : 1

AMS 800 Artificial Urinary Sphincter - 00878953000640 Catalog Number :

Device Description : Pressure Regulating Balloon, Pressure: 81-90 cm H20

Device Class : 3

Duns Number: 125111448

Premarket Exempt : No

Product Code : EZY

Prescription Use : Yes

Device Count : 1

AMS 800 Artificial Urinary Sphincter - 00878953000657 Catalog Number :

Device Description : Pressure Regulating Balloon, Pressure: 91-100 cm H20

Device Class : 3

Duns Number: 125111448

Premarket Exempt : No

Product Code : EZY

Prescription Use : Yes

Device Count : 1

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