Suture, Surgical, Absorbable, Polydioxanone (NEW) contract manufacturers
10 US facilities list FDA product code NEW as a contract manufacturer (1) or contract sterilizer (9).
FDA-registered (openFDA, export of Oct 21, 2026)
- FDA device name
- Suture, Surgical, Absorbable, Polydioxanone
- Product code
- NEW (FDA product classification database)
- Device class
- Class II
- Regulation
- 21 CFR 878.4840
- Classification panel
- General and plastic surgery
- FDA flags
- implant
Where they are
Tennessee 2 · California 1 · Georgia 1 · Massachusetts 1 · Minnesota 1 · New Jersey 1 · Pennsylvania 1 · Puerto Rico 1 · Utah 1
All 10 facilities
| Company | FDA registration | Establishment type | Device categories | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| Isomedix Operations Inc. | 2246552 | Contract sterilizer | General and plastic surgery; Orthopedic; Gastroenterology and urology +12 more | S Plainfield, NJ | 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 |
| Isomedix Operations, Inc. | 2183744 | Contract sterilizer | Cardiovascular; General and plastic surgery; Gastroenterology and urology +13 more | Minneapolis, MN | Not verified | Oct 21, 2026 |
| LYNX Medical Pennsylvania | 2528981 | Contract sterilizer | Orthopedic; Gastroenterology and urology; Cardiovascular +8 more | Erie, PA | Not verified | Oct 21, 2026 |
| Performance Fibers OEM LLC | 1221601 | Contract manufacturer | General and plastic surgery; Cardiovascular; Orthopedic | Mansfield, MA | Not verified | Oct 21, 2026 |
| STERITECH, INC. | 2650143 | Contract sterilizer | General and plastic surgery; Orthopedic; General hospital +6 more | Salinas, PR | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 1018470 | Contract sterilizer | General and plastic surgery; Orthopedic; General hospital +12 more | Atlanta, GA | 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 |
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