Scalpel, One-Piece (GDX) contract manufacturers
20 US facilities list FDA product code GDX as a contract manufacturer (8) or contract sterilizer (12).
FDA-registered (openFDA, export of Oct 21, 2026)
- FDA device name
- Scalpel, One-Piece
- Product code
- GDX (FDA product classification database)
- Device class
- Class I
- Regulation
- 21 CFR 878.4800
- Classification panel
- General and plastic surgery
Where they are
California 5 · Florida 2 · Illinois 2 · Tennessee 2 · Indiana 1 · Michigan 1 · Minnesota 1 · North Carolina 1 · New Mexico 1 · Ohio 1 · Pennsylvania 1 · Puerto Rico 1 and 1 more states
All 20 facilities
| Company | FDA registration | Establishment type | Device categories | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| Apollo Renal Therapeutics, LLC | 3010032115 | Contract manufacturer | General and plastic surgery; Anesthesiology; General hospital +2 more | Ocala, FL | Not verified | Oct 21, 2026 |
| Avalign Instruments & Implants | 3006128100 | Contract manufacturer | Orthopedic; General and plastic surgery; Neurology +5 more | Fort Wayne, IN | Not verified | Oct 21, 2026 |
| CADENCE DEVICE, INC. | 3010659131 | Contract manufacturer | Orthopedic; General hospital; General and plastic surgery +3 more | Cranberry Township, PA | Not verified | Oct 21, 2026 |
| DeRoyal Industries, Inc. | 1054241 | Contract sterilizer | General and plastic surgery; General hospital; Gastroenterology and urology +14 more | New Tazewell, TN | Not verified | Oct 21, 2026 |
| DEROYAL INDUSTRIES, INC. | 1055236 | Contract sterilizer | General and plastic surgery; General hospital; Gastroenterology and urology +14 more | New Tazewell, TN | Not verified | Oct 21, 2026 |
| GRIFF INDUSTRIES, INC. | 2031528 | Contract manufacturer | General and plastic surgery | Lancaster, CA | Not verified | Oct 21, 2026 |
| ISOMEDIX OPERATIONS INC | 1526711 | Contract sterilizer | Orthopedic; General and plastic surgery; General hospital +10 more | Groveport, OH | Not verified | Oct 21, 2026 |
| Isomedix Operations, Inc | 2032098 | Contract sterilizer | Orthopedic; General and plastic surgery; General hospital +12 more | Ontario, CA | Not verified | Oct 21, 2026 |
| Isomedix Operations, Inc. | 1450662 | Contract sterilizer | Orthopedic; General and plastic surgery; Cardiovascular +11 more | Libertyville, IL | Not verified | Oct 21, 2026 |
| KLUGE DESIGN INC. | 3003661577 | Contract manufacturer | Gastroenterology and urology; Cardiovascular; General and plastic surgery +1 more | Rogers, MN | Not verified | Oct 21, 2026 |
| LIFE SCIENCE OUTSOURCING, INC. | 2031093 | Contract manufacturer | Orthopedic; General and plastic surgery; Neurology +7 more | Brea, CA | Not verified | Oct 21, 2026 |
| MEDBIO Clinton Township | 3031481074 | Contract manufacturer | General and plastic surgery | Clinton Township, MI | Not verified | Oct 21, 2026 |
| Nypro Healthcare Baja Inc. (Albuquerque) | 3015183635 | Contract sterilizer | General and plastic surgery; Orthopedic; Gastroenterology and urology +3 more | Albuquerque, NM | Not verified | Oct 21, 2026 |
| Sterigenics U.S. LLC | 1054811 | Contract sterilizer | Orthopedic; General and plastic surgery; Ophthalmic +13 more | Mulberry, FL | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 2029275 | Contract sterilizer | General and plastic surgery; Orthopedic; Cardiovascular +16 more | Corona, CA | Not verified | Oct 21, 2026 |
| Sterigenics US LLC | 1058584 | Contract sterilizer | General and plastic surgery; Orthopedic; General hospital +14 more | Charlotte, NC | Not verified | Oct 21, 2026 |
| Sterigenics US LLC | 1423662 | Contract sterilizer | Orthopedic; General and plastic surgery; General hospital +14 more | Gurnee, IL | Not verified | Oct 21, 2026 |
| STERILIZATION SERVICES OF VIRGINIA | 1123137 | Contract sterilizer | General and plastic surgery; Cardiovascular; General hospital +9 more | Richmond, VA | Not verified | Oct 21, 2026 |
| STERIS ISOMEDIX PUERTO RICO, INC. | 2648623 | Contract sterilizer | Orthopedic; General and plastic surgery; Cardiovascular +5 more | Alts De Cerro Gordo 3&4, PR | Not verified | Oct 21, 2026 |
| SURGISTAR, INC. | 2028661 | Contract manufacturer | Ophthalmic; General and plastic surgery | Vista, CA | Not verified | Oct 21, 2026 |
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