Endoscopic Injection Needle, Gastroenterology-Urology (FBK) contract manufacturers
12 US facilities list FDA product code FBK as a contract manufacturer (5) or contract sterilizer (7).
FDA-registered (openFDA, export of Oct 21, 2026)
- FDA device name
- Endoscopic Injection Needle, Gastroenterology-Urology
- Product code
- FBK (FDA product classification database)
- Device class
- Class II
- Regulation
- 21 CFR 876.1500
- Classification panel
- Gastroenterology and urology
Where they are
Texas 3 · Utah 2 · Connecticut 1 · Florida 1 · Indiana 1 · Michigan 1 · New Jersey 1 · Ohio 1 · South Carolina 1
All 12 facilities
| Company | FDA registration | Establishment type | Device categories | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| COOK INCORPORATED | 1000393132 | Contract sterilizer | Gastroenterology and urology; General and plastic surgery; Cardiovascular +8 more | Ellettsville, IN | Not verified | Oct 21, 2026 |
| HART ENTERPRISES, INC. | 1828424 | Contract manufacturer | General and plastic surgery; Cardiovascular; Anesthesiology +1 more | Sparta, MI | Not verified | Oct 21, 2026 |
| HOBBS MEDICAL, INC. | 1220592 | Contract manufacturer | Gastroenterology and urology; Ear, nose and throat | Stafford Springs, CT | Not verified | Oct 21, 2026 |
| INTERNATIONAL STERILIZATION LABORATORY, LLC | 1061927 | Contract sterilizer | Orthopedic; General and plastic surgery; Gastroenterology and urology +9 more | Groveland, FL | 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. | 1047843 | Contract sterilizer | General and plastic surgery; Gastroenterology and urology; Orthopedic +13 more | Spartanburg, SC | 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 |
| Isomedix Operations Inc. | 2246552 | Contract sterilizer | General and plastic surgery; Orthopedic; Gastroenterology and urology +12 more | S Plainfield, NJ | Not verified | Oct 21, 2026 |
| MEDRON, LLC | 1722746 | Contract manufacturer | Gastroenterology and urology; Cardiovascular; General hospital +3 more | Salt Lake City, UT | Not verified | Oct 21, 2026 |
| Nissha Medical Technologies (Ohio), Inc. | 1519132 | Contract manufacturer | Gastroenterology and urology; Obstetrics and gynecology; General and plastic surgery +2 more | Norwalk, OH | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 1721676 | Contract manufacturer | Cardiovascular; Orthopedic; General and plastic surgery +12 more | Salt Lake City, UT | Not verified | Oct 21, 2026 |
| Steritec Services, LLC | 1647149 | Contract sterilizer | Gastroenterology and urology; Orthopedic; Cardiovascular +4 more | Athens, TX | Not verified | Oct 21, 2026 |
Related gastroenterology and urology product codes
- GCJ Laparoscope, General & Plastic Surgery (96)
- KNW Instrument, Biopsy (69)
- KNT Tubes, Gastrointestinal (And Accessories) (47)
- FGE Stents, Drains And Dilators For The Biliary Ducts (30)
- FCG Biopsy Needle (27)
- NAY System, Surgical, Computer Controlled Instrument (25)
- KOD Catheter, Urological (24)
- EZL Catheter, Retention Type, Balloon (23)