Speculum, Vaginal, Nonmetal (HIB) contract manufacturers
10 US facilities list FDA product code HIB as a contract manufacturer (4) or contract sterilizer (6).
FDA-registered (openFDA, export of Oct 21, 2026)
- FDA device name
- Speculum, Vaginal, Nonmetal
- Product code
- HIB (FDA product classification database)
- Device class
- Class II
- Regulation
- 21 CFR 884.4530
- Classification panel
- Obstetrics and gynecology
Where they are
New York 3 · Tennessee 2 · California 1 · Georgia 1 · Indiana 1 · North Carolina 1 · Texas 1
All 10 facilities
| Company | FDA registration | Establishment type | Device categories | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| ALLIANCE PRECISION PLASTICS | 1319480 | Contract manufacturer | Gastroenterology and urology; Obstetrics and gynecology; Ophthalmic +1 more | Gates, NY | Not verified | Oct 21, 2026 |
| BIOSEAL | 2027062 | Contract manufacturer | General and plastic surgery; General hospital; Orthopedic +12 more | Placentia, CA | 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 |
| GLOBAL PLASTICS, INC. | 1835058 | Contract manufacturer | Obstetrics and gynecology | Indianapolis, IN | 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 | 1061124 | Contract sterilizer | General and plastic surgery; Gastroenterology and urology; General hospital +15 more | Charlotte, NC | 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 US LLC | 3004111573 | Contract sterilizer | General and plastic surgery; Gastroenterology and urology; General hospital +15 more | Grand Prairie, TX | Not verified | Oct 21, 2026 |
| TESSY PLASTICS CORP. | 1317202 | Contract manufacturer | Clinical chemistry; General and plastic surgery; Ear, nose and throat +3 more | Elbridge, NY | Not verified | Oct 21, 2026 |
Related obstetrics and gynecology product codes
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- HGI Electrocautery, Gynecologic (And Accessories) (22)
- NUC Lubricant, Personal (22)
- LKF Cannula, Manipulator/Injector, Uterine (20)
- KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) (16)
- OHM Cesarean Section Tray (14)