Catheter Introducer Kit (OFC) contract manufacturers
8 US facilities list FDA product code OFC as a contract manufacturer (1) or contract sterilizer (7).
FDA-registered (openFDA, export of Oct 21, 2026)
- FDA device name
- Catheter Introducer Kit
- Product code
- OFC (FDA product classification database)
- Device class
- Class II
- Regulation
- 21 CFR 870.1340
- Classification panel
- Cardiovascular
Where they are
Texas 4 · California 1 · Colorado 1 · Massachusetts 1 · North Carolina 1
All 8 facilities
| Company | FDA registration | Establishment type | Device categories | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| 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 |
| ISOMEDIX OPERATIONS INC. | 1220477 | Contract sterilizer | Orthopedic; General and plastic surgery; General hospital +14 more | Northborough, MA | Not verified | Oct 21, 2026 |
| Isomedix Operations, Inc. | 2030624 | Contract sterilizer | Cardiovascular; General and plastic surgery; Gastroenterology and urology +11 more | Temecula, CA | Not verified | Oct 21, 2026 |
| MAINSTREAM MEDICAL DEVICES | 3016112537 | Contract manufacturer | Orthopedic; General and plastic surgery; Cardiovascular +4 more | Austin, TX | 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 |
| Terumo BCT STERILIZATION SERVICES, Inc. | 1724474 | Contract sterilizer | Cardiovascular; General and plastic surgery; Gastroenterology and urology +6 more | Lakewood, CO | Not verified | Oct 21, 2026 |
Related cardiovascular product codes
- DYB Introducer, Catheter (62)
- DQY Catheter, Percutaneous (56)
- DWS Instruments, Surgical, Cardiovascular (55)
- DQX Wire, Guide, Catheter (52)
- DXC Clamp, Vascular (49)
- DQO Catheter, Intravascular, Diagnostic (40)
- DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (39)
- DXT Injector And Syringe, Angiographic (38)