Athena Surgical LLC

Address:6110 Blue Circle Drive,Minnetonka,MN,55343,US

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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) (3)

Premarket Exempt

Clear

Athena Surgical RMUS System - 00860003619803 Catalog Number :

Device Description : Instrument Handle

Device Class : 2

Duns Number: 117067792

Premarket Exempt : No

Product Code : OTN

Prescription Use : Yes

Device Count : 1

Athena Surgical RMUS System - 00860003619810 Catalog Number :

Device Description : Mid-Urethral Sling Assembly, Round Needles

Device Class :

Duns Number: 117067792

Premarket Exempt : No

Product Code : OTN

Prescription Use : Yes

Device Count : 1

Athena Surgical RMUS System - 00860003619827 Catalog Number :

Device Description : Mid-Urethral Sling Assembly, Flat Needles

Device Class :

Duns Number: 117067792

Premarket Exempt : No

Product Code : OTN

Prescription Use : Yes

Device Count : 1

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