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

Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator (OTN) (8) Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed (OTO) (1) Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling (PAH) (1)

Premarket Exempt

No Yes

Clear

Monarc - 00814723020319 Catalog Number : 72403830

Device Description : Monarc

Device Class : 2

Duns Number: 178074951

Premarket Exempt : No

Product Code : OTN

Prescription Use : Yes

Device Count : 1

IntePro Y-Mesh - 00814723020333 Catalog Number : 72404000

Device Description : IntePro Y-Mesh

Device Class : 2

Duns Number: 178074951

Premarket Exempt : No

Product Code : OTO

Prescription Use : Yes

Device Count : 1

Monarc - 00814723020340 Catalog Number : 72404193

Device Description : Monarc +

Device Class : 2

Duns Number: 178074951

Premarket Exempt : No

Product Code : OTN

Prescription Use : Yes

Device Count : 1

Monarc - 00814723020357 Catalog Number : 72404195

Device Description : Monarc C

Device Class : 2

Duns Number: 178074951

Premarket Exempt : No

Product Code : OTN

Prescription Use : Yes

Device Count : 1

MiniArc - 00814723020364 Catalog Number : 9000261

Device Description : MiniArc Pro

Device Class : 2

Duns Number: 178074951

Premarket Exempt : No

Product Code : PAH

Prescription Use : Yes

Device Count : 1

RetroArc - 00814723020371 Catalog Number : 9000262

Device Description : RetroArc

Device Class : 2

Duns Number: 178074951

Premarket Exempt : No

Product Code : OTN

Prescription Use : Yes

Device Count : 1

NA - 00814723020401 Catalog Number : 1006241

Device Description : Sling Mesh

Device Class : 2

Duns Number: 178074951

Premarket Exempt : No

Product Code : OTN

Prescription Use : Yes

Device Count : 1

SPARC - 00814723020425 Catalog Number : 1006228

Device Description : SPARC Needle Passers

Device Class : 2

Duns Number: 178074951

Premarket Exempt : No

Product Code : OTN

Prescription Use : Yes

Device Count : 1

Monarc - 00814723020449 Catalog Number : 1006229

Device Description : Monarc Needle Passers

Device Class : 2

Duns Number: 178074951

Premarket Exempt : No

Product Code : OTN

Prescription Use : Yes

Device Count : 1

Monarc - 00814723020463 Catalog Number : 1006230

Device Description : Monarc + Needle Passers

Device Class : 2

Duns Number: 178074951

Premarket Exempt : No

Product Code : OTN

Prescription Use : Yes

Device Count : 1

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