# Isomedix Operations Inc. (contract sterilizer, Northborough, MA): 26 new FDA device listings, incl. thoracolumbosacral pedicle screw system

**Score:** 90/100

| Field | Value |
|---|---|
| Establishment | Isomedix Operations Inc. |
| Owner / operator | STERIS Corporation |
| Role | Contract sterilizer |
| Establishment types | Sterilize Medical Device for Another Party (Contract Sterilizer) |
| Location | Northborough, MA, US |
| New listings | 26 |
| Devices | Thoracolumbosacral Pedicle Screw System; Catheter, Intravascular, Diagnostic; System, Imaging, Optical Coherence Tomography (Oct); Prosthesis, Vascular Graft, Of Less Then 6mm Diameter; Prosthesis, Vascular Graft, Of 6mm And Greater Diameter; Fastener, Fixation, Nondegradable, Soft Tissue; Intervertebral Fusion Device With Bone Graft, Lumbar; Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use; Introducer, Catheter; Pump, Infusion, Insulin Bolus |
| Product codes | NKB, DQO, NQQ, DYF, DSY, MBI, MAX, JQC, DYB, OPP, LZG, QVI, OVB, KWP, KWQ |
| Device classes | Class I, Class II |
| Medical specialties | Orthopedic, Cardiovascular, Radiology, Clinical Chemistry, General Hospital, Gastroenterology, Urology |
| Brand names | Gentuity7546 (NR) - Gentuity HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter; Atrium1623 (NR) - Advanta VXT Vascular Graft <6mm; Atrium1623 (NR) - Advanta VXT Vascular Graft >6mm; Atrium1623 (NR) - Flixene Vascular Graft <6mm; Atrium1623 (NR) - Flixene Vascular Graft >6mm; SpineWave3277 (NR) - Exceed® Biplanar Expandable Interbody System; TerumoMed3380 (NR) -Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding; Woven10921 (NR,CH1*) - Ogmend Implant Enhancement System |
| First new listing | 2026-06-01 |
| Latest new listing | 2026-10-21 |
| FDA registration number | 1220477 |
| Registration expires | 2027-12-31 |

## Why this score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
- Listed in the last 45 days.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.