CL MEDICAL

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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) (5) Mesh, Surgical, For Stress Urinary Incontinence, Male (OTM) (1)

Premarket Exempt

Clear

I-STOP - 03760151650048 Catalog Number :

Device Description : Sling for female incontinence

Device Class : 2

Duns Number: 262825552

Premarket Exempt : No

Product Code : OTN

Prescription Use : No

Device Count : 1

I-STOP - 03760151650055 Catalog Number :

Device Description : Sling for female incontinence

Device Class : 2

Duns Number: 262825552

Premarket Exempt : No

Product Code : OTN

Prescription Use : No

Device Count : 1

I-STOP - 03760151650093 Catalog Number :

Device Description : Sling for female incontinence

Device Class : 2

Duns Number: 262825552

Premarket Exempt : No

Product Code : OTN

Prescription Use : No

Device Count : 1

I-STOP - 03760151650185 Catalog Number :

Device Description : Sling for female incontinence

Device Class : 2

Duns Number: 262825552

Premarket Exempt : No

Product Code : OTN

Prescription Use : No

Device Count : 1

I-STOP TOMS - 03760151650239 Catalog Number :

Device Description : Sling for male incontinence

Device Class : 2

Duns Number: 262825552

Premarket Exempt : No

Product Code : OTM

Prescription Use : No

Device Count : 1

I-STOP - 03760151650338 Catalog Number :

Device Description : Sling for female incontinence

Device Class : 2

Duns Number: 262825552

Premarket Exempt : No

Product Code : OTN

Prescription Use : No

Device Count : 1

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