# Isomedix Operations Inc. (contract sterilizer, Northborough, MA): 18 new FDA device listings, incl. introducer, catheter

**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 | 18 |
| Devices | Introducer, Catheter; Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use; Fastener, Fixation, Nondegradable, Soft Tissue; Clamp, Vascular; Screw Sleeve Bone Fixation Device, Spine; Thoracolumbosacral Pedicle Screw System; Hydrogel Spacer; Prosthesis, Vascular Graft, Of Less Then 6mm Diameter; Prosthesis, Vascular Graft, Of 6mm And Greater Diameter; Appliance, Fixation, Spinal Interlaminal |
| Product codes | DYB, JQC, MBI, DXC, QVI, NKB, OVB, DYF, DSY, KWP, KWQ, DQO, NQQ, KWD, OPP |
| Device classes | Class I, Class II |
| Medical specialties | Cardiovascular, Clinical Chemistry, Orthopedic, Radiology, General Hospital |
| Brand names | TerumoMed3380 (NR) -Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding; TerumoMed3380 (NR) - TR Band; TR BAND Radial Compression Device; Woven10921 (NR,CH1*) - Ogmend Implant Enhancement System; Atrium1623 (NR) - Flixene Vascular Graft >6mm; Atrium1623 (NR) - Advanta VXT Vascular Graft >6mm; Atrium1623 (NR) - Flixene Vascular Graft <6mm; Atrium1623 (NR) - Advanta VXT Vascular Graft <6mm; Gentuity7546 (NR) - Gentuity HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter |
| First new listing | 2026-06-01 |
| Latest new listing | 2026-09-25 |
| 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: 2026-10-28T20:51:27.468Z.
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.