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
| Company | FDA registration | Establishment type | Device categories | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| Aprios Custom Mfg. | 3004612223 | Contract manufacturer | General and plastic surgery; Clinical chemistry; Ear, nose and throat +1 more | Minneapolis, MN | Not verified | Oct 21, 2026 |
| BARD SHANNON LIMITED | 3005636544 | Contract manufacturer | General and plastic surgery; Gastroenterology and urology; Radiology +2 more | Humacao, PR | Not verified | Oct 21, 2026 |
| BIOMERICS Advanced Catheter | 3012159165 | Contract manufacturer | Cardiovascular; Gastroenterology and urology; General and plastic surgery | Brooklyn Park, MN | Not verified | Oct 21, 2026 |
| C.R. BARD, INC. | 1018233 | Contract sterilizer | Gastroenterology and urology; Cardiovascular; General and plastic surgery +4 more | Covington, GA | Not verified | Oct 21, 2026 |
| C.R. BARD, INC. | 3006082230 | Contract sterilizer | Gastroenterology and urology; Cardiovascular; General and plastic surgery +4 more | Madison, GA | Not verified | Oct 21, 2026 |
| I-Tek Medical, Inc. | 3008627763 | Contract manufacturer | General and plastic surgery; Cardiovascular; Gastroenterology and urology +3 more | White Bear Lake, MN | Not verified | Oct 21, 2026 |
| Isomedix Operations, Inc. | 2183744 | Contract sterilizer | Cardiovascular; General and plastic surgery; Gastroenterology and urology +13 more | Minneapolis, MN | Not verified | Oct 21, 2026 |
| LISI MEDICAL Remmele | 3000203391 | Contract manufacturer | Orthopedic; Dental; General and plastic surgery +1 more | Coon Rapids, MN | Not verified | Oct 21, 2026 |
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