ENDO PHARMACEUTICALS INC.

ENDO PHARMACEUTICALS 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

Instrument, Manual, Surgical, General Use (MDM) (3) Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed (OTP) (2) Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling (PAH) (2) Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator (OTN) (1)

Premarket Exempt

No Yes

Clear

Valstar - 00367979001002 Catalog Number :

Device Class :

Duns Number: 178074951

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Supprelin LA - 00367979002009 Catalog Number :

Device Description : Supprelin Kit

Device Class : 1

Duns Number: 178074951

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

Vantas - 00367979005000 Catalog Number :

Device Class : 1

Duns Number: 178074951

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

TestoPak - 00367979723003 Catalog Number :

Device Class :

Duns Number: 178074951

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

N/A - 00367979855001 Catalog Number :

Device Class : 1

Duns Number: 178074951

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

MiniArc - 00814723020036 Catalog Number : 720046-01

Device Description : MiniArc

Device Class : 2

Duns Number: 178074951

Premarket Exempt : No

Product Code : PAH

Prescription Use : Yes

Device Count : 1

Elevate - 00814723020050 Catalog Number : 720093-01

Device Description : Elevate Anterior & Apical

Device Class : 3

Duns Number: 178074951

Premarket Exempt : No

Product Code : OTP

Prescription Use : Yes

Device Count : 1

Elevate - 00814723020067 Catalog Number : 720127-01

Device Description : Elevate Apical & Posterior

Device Class : 3

Duns Number: 178074951

Premarket Exempt : No

Product Code : OTP

Prescription Use : Yes

Device Count : 1

MiniArc - 00814723020104 Catalog Number : 720191-01

Device Description : MiniArc Precise

Device Class : 2

Duns Number: 178074951

Premarket Exempt : No

Product Code : PAH

Prescription Use : Yes

Device Count : 1

SPARC - 00814723020296 Catalog Number : 72403656

Device Description : SPARC

Device Class : 2

Duns Number: 178074951

Premarket Exempt : No

Product Code : OTN

Prescription Use : Yes

Device Count : 1

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