Wire, Guide, Catheter, Exempt (PTL) contract manufacturers
8 US facilities list FDA product code PTL as a contract manufacturer (4) or contract sterilizer (4).
FDA-registered (openFDA, export of Oct 21, 2026)
- FDA device name
- Wire, Guide, Catheter, Exempt
- Product code
- PTL (FDA product classification database)
- Device class
- Class II
- Regulation
- 21 CFR 870.1330
- Classification panel
- Cardiovascular
Where they are
California 2 · Utah 2 · Colorado 1 · North Carolina 1 · New York 1 · Vermont 1
All 8 facilities
| Company | FDA registration | Establishment type | Device categories | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| DYNAFLEX TECHNOLOGIES | 3013341368 | Contract manufacturer | Cardiovascular | Irvine, CA | Not verified | Oct 21, 2026 |
| Gilero, Inc | 3016733629 | Contract manufacturer | General hospital; Cardiovascular; Anesthesiology +3 more | Pittsboro, NC | Not verified | Oct 21, 2026 |
| MERIT MEDICAL SYSTEMS, INC. | 1721504 | Contract manufacturer | Cardiovascular; General and plastic surgery; Gastroenterology and urology +2 more | South Jordan, UT | Not verified | Oct 21, 2026 |
| Nolato GW BETHEL | 1219536 | Contract manufacturer | Cardiovascular; General and plastic surgery | Bethel, VT | Not verified | Oct 21, 2026 |
| STERI-TEK | 3012448339 | Contract sterilizer | General and plastic surgery; Cardiovascular; Ear, nose and throat +8 more | Fremont, CA | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 1319639 | Contract sterilizer | Cardiovascular; General and plastic surgery; Gastroenterology and urology +14 more | Queensbury, NY | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 1721676 | Contract sterilizer | Cardiovascular; Orthopedic; General and plastic surgery +12 more | Salt Lake City, UT | 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)