# Stellmacher Instruments Inc (repackager or relabeler, Orlando, FL): 30 new FDA device listings, incl. handle, scalpel

**Score:** 75/100

| Field | Value |
|---|---|
| Establishment | Stellmacher Instruments Inc |
| Role | Repackager or relabeler |
| Establishment types | Repack or Relabel Medical Device |
| Location | Orlando, FL, US |
| New listings | 30 |
| Devices | Handle, Scalpel; Punch, Corneo-Scleral; Cable, Electrode; Dilator, Lachrymal; Retractor, Ophthalmic; Probe, Lachrymal; Orthopedic Manual Surgical Instrument; Scissors, Medical, Disposable; Cannula, Ophthalmic; Marker, Skin |
| Product codes | GDZ, HNJ, IKD, HNW, HNI, HNL, LXH, JOK, HMX, FZZ, GAD, GEN, GAT, GEI, CCW |
| Device classes | Class I, Class II |
| Medical specialties | General, Plastic Surgery, Ophthalmic, Physical Medicine, Orthopedic, General Hospital, Anesthesiology, Obstetrics/Gynecology |
| Brand names | Infusion handle, m-f connectors, overall length 9.5 cm; Infusion handle, male / tube connectors, overall length 7.5 cm; Trephine Blade, size 3 mm, overall length 10 cm; Scalpel handle No. 3, overall length 12.5 cm; Chuck handle, Round Serrated, overall length 10 cm; Infusion Handle Degree guage, beveled, with 4 notches to adjust at the alignment marks, 16 mm; Infusion handle, m-m connectors, overall length 10 cm; Kelly Descemet’s membrane punch, 1 mm x 0.75 mm, overall length 13.5 cm |
| First new listing | 2026-05-12 |
| Latest new listing | 2026-09-24 |
| FDA registration number | 3029754081 |
| Registration expires | 2026-12-31 |

## Why this score
- 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.