MedtechSourcebook

Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator (OTN) contract manufacturers

8 US facilities list FDA product code OTN as a contract manufacturer (5) or contract sterilizer (3).

FDA-registered (openFDA, export of Oct 21, 2026)

FDA device name
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Product code
OTN (FDA product classification database)
Device class
Class II
Regulation
21 CFR 878.3300
Classification panel
General and plastic surgery
FDA flags
implant

Where they are

Minnesota 5 · Georgia 2 · Puerto Rico 1

All 8 facilities

CompanyFDA registrationEstablishment typeDevice categoriesCity and stateCertificationUpdated
Aprios Custom Mfg.3004612223Contract manufacturerGeneral and plastic surgery; Clinical chemistry; Ear, nose and throat +1 moreMinneapolis, MNNot verifiedOct 21, 2026
BARD SHANNON LIMITED3005636544Contract manufacturerGeneral and plastic surgery; Gastroenterology and urology; Radiology +2 moreHumacao, PRNot verifiedOct 21, 2026
BIOMERICS Advanced Catheter3012159165Contract manufacturerCardiovascular; Gastroenterology and urology; General and plastic surgeryBrooklyn Park, MNNot verifiedOct 21, 2026
C.R. BARD, INC.1018233Contract sterilizerGastroenterology and urology; Cardiovascular; General and plastic surgery +4 moreCovington, GANot verifiedOct 21, 2026
C.R. BARD, INC.3006082230Contract sterilizerGastroenterology and urology; Cardiovascular; General and plastic surgery +4 moreMadison, GANot verifiedOct 21, 2026
I-Tek Medical, Inc.3008627763Contract manufacturerGeneral and plastic surgery; Cardiovascular; Gastroenterology and urology +3 moreWhite Bear Lake, MNNot verifiedOct 21, 2026
Isomedix Operations, Inc.2183744Contract sterilizerCardiovascular; General and plastic surgery; Gastroenterology and urology +13 moreMinneapolis, MNNot verifiedOct 21, 2026
LISI MEDICAL Remmele3000203391Contract manufacturerOrthopedic; Dental; General and plastic surgery +1 moreCoon Rapids, MNNot verifiedOct 21, 2026

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