Syringe, Balloon Inflation, Exempt (PTM) contract manufacturers
5 US facilities list FDA product code PTM as a contract manufacturer (1) or contract sterilizer (4).
FDA-registered (openFDA, export of Oct 21, 2026)
- FDA device name
- Syringe, Balloon Inflation, Exempt
- Product code
- PTM (FDA product classification database)
- Device class
- Class II
- Regulation
- 21 CFR 870.1650
- Classification panel
- Cardiovascular
Where they are
Alabama 1 · California 1 · Colorado 1 · South Carolina 1 · Utah 1
All 5 facilities
| Company | FDA registration | Establishment type | Device categories | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| ATRION MEDICAL PRODUCTS, INC. | 1043729 | Contract manufacturer | Ear, nose and throat; Cardiovascular; General hospital +1 more | Arab, AL | Not verified | Oct 21, 2026 |
| ISOMEDIX OPERATIONS INC. | 1047843 | Contract sterilizer | General and plastic surgery; Gastroenterology and urology; Orthopedic +13 more | Spartanburg, SC | 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 |
| 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 |
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