Dilator, Rectal (FFP) contract manufacturers
8 US facilities list FDA product code FFP as a contract manufacturer (4) or contract sterilizer (5).
FDA-registered (openFDA, export of Oct 21, 2026)
- FDA device name
- Dilator, Rectal
- Product code
- FFP (FDA product classification database)
- Device class
- Class I
- Regulation
- 21 CFR 876.5450
- Classification panel
- Gastroenterology and urology
Where they are
Texas 3 · Florida 1 · Illinois 1 · North Carolina 1 · New Hampshire 1 · New Mexico 1
All 8 facilities
| Company | FDA registration | Establishment type | Device categories | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| DESIGN STANDARDS CORP. | 1222274 | Contract manufacturer | General and plastic surgery; Orthopedic; Gastroenterology and urology | Charlestown, NH | Not verified | Oct 21, 2026 |
| ISOMEDIX OPERATIONS INC | 1643817 | Contract sterilizer | General and plastic surgery; Gastroenterology and urology; Cardiovascular +14 more | El Paso, TX | Not verified | Oct 21, 2026 |
| Isomedix Operations Inc | 3009888344 | Contract sterilizer | Gastroenterology and urology; General and plastic surgery; General hospital +13 more | El Paso, TX | Not verified | Oct 21, 2026 |
| Nypro Healthcare Baja Inc. (Albuquerque) | 3015183635 | Contract manufacturer and sterilizer | General and plastic surgery; Orthopedic; Gastroenterology and urology +3 more | Albuquerque, NM | Not verified | Oct 21, 2026 |
| PHOENIX INSTRUMENTS, INC. | 1421879 | Contract manufacturer | General and plastic surgery; Ear, nose and throat; Dental +9 more | Lisle, IL | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 1061124 | Contract sterilizer | General and plastic surgery; Gastroenterology and urology; General hospital +15 more | Charlotte, NC | Not verified | Oct 21, 2026 |
| Sterigenics US LLC | 3004111573 | Contract sterilizer | General and plastic surgery; Gastroenterology and urology; General hospital +15 more | Grand Prairie, TX | Not verified | Oct 21, 2026 |
| TMF PLASTIC SOLUTIONS LLC | 3017087293 | Contract manufacturer | Anesthesiology; Gastroenterology and urology | Bradenton, FL | Not verified | Oct 21, 2026 |
Related gastroenterology and urology product codes
- GCJ Laparoscope, General & Plastic Surgery (96)
- KNW Instrument, Biopsy (69)
- KNT Tubes, Gastrointestinal (And Accessories) (47)
- FGE Stents, Drains And Dilators For The Biliary Ducts (30)
- FCG Biopsy Needle (27)
- NAY System, Surgical, Computer Controlled Instrument (25)
- KOD Catheter, Urological (24)
- EZL Catheter, Retention Type, Balloon (23)