# Stephens Instruments, Inc (repackager or relabeler, Lexington, KY): 13 new FDA device listings, incl. spoon, ophthalmic

**Score:** 65/100

| Field | Value |
|---|---|
| Establishment | Stephens Instruments, Inc |
| Owner / operator | Stephens Instruments, Inc. |
| Role | Repackager or relabeler |
| Establishment types | Repack or Relabel Medical Device |
| Location | Lexington, KY, US |
| New listings | 13 |
| Devices | Spoon, Ophthalmic; Clip, Tantalum, Ophthalmic; Marker, Ocular; Holder, Needle, Gastroenterologic; Handle, Scalpel; Needle, Aspiration And Injection, Reusable; Dissector, Surgical, General & Plastic Surgery; Instrument, Measuring, Corneal Radius; Unit, Syringe, Air And/Or Water; Forceps |
| Product codes | HNB, HQW, HMR, FHQ, GDZ, GDM, GDI, HJB, ECB, HTD, OHW, HOD, HOG |
| Device classes | Class I, Class II |
| Medical specialties | Ophthalmic, Gastroenterology, Urology, General, Plastic Surgery, Dental |
| Brand names | Ophthalmic Spoon; Clip, Tantalum, Ophthalmic; Ocular Marker; Needle Holder; Scalpel; Aspiration Needle; Dissector; Corneal radius measurement instrument |
| First new listing | 2026-06-03 |
| Latest new listing | 2026-07-01 |
| FDA registration number | 1045379 |
| Registration expires | 2027-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.

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.