Pap Smear Kit (OHL) contract manufacturers
8 US facilities list FDA product code OHL as a contract manufacturer (2) or contract sterilizer (6).
FDA-registered (openFDA, export of Oct 21, 2026)
- FDA device name
- Pap Smear Kit
- Product code
- OHL (FDA product classification database)
- Device class
- Class II
- Regulation
- 21 CFR 884.4530
- Classification panel
- Obstetrics and gynecology
Where they are
Tennessee 3 · Texas 3 · Connecticut 1 · North Carolina 1
All 8 facilities
| Company | FDA registration | Establishment type | Device categories | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| AERO-MED LLC | 3006191977 | Contract manufacturer | General hospital; Pathology; General and plastic surgery +4 more | East Hartford, CT | 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 |
| DEROYAL INDUSTRIES, INC. | 2320762 | Contract manufacturer | General and plastic surgery; General hospital; Gastroenterology and urology +7 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 | 1643817 | Contract sterilizer | General and plastic surgery; Gastroenterology and urology; Cardiovascular +14 more | El Paso, TX | Not verified | Oct 21, 2026 |
| Isomedix Operations Inc | 3009888344 | Contract sterilizer | Gastroenterology and urology; General and plastic surgery; General hospital +13 more | El Paso, TX | 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 US LLC | 3004111573 | Contract sterilizer | General and plastic surgery; Gastroenterology and urology; General hospital +15 more | Grand Prairie, TX | Not verified | Oct 21, 2026 |
Related obstetrics and gynecology product codes
- HET Laparoscope, Gynecologic (And Accessories) (30)
- HIF Insufflator, Laparoscopic (24)
- HIH Hysteroscope (And Accessories) (24)
- 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)