Contract manufacturerNUELL, INC. (Leesburg, IN)IndianaGeneral and plastic surgeryOrthopedicClass I
NUELL, INC.
Contract manufacturer ยท Leesburg, IN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1827813 (openFDA record; or search FDA's registration database)
- FEI number
- 1827813
- Registered for
- FDA registration year 2026
- Establishment types
- Specification developer; Manufacturer; Contract manufacturer; Repackager or relabeler
- Owner or operator
- NUELL, INC. (FDA owner/operator no. 1827813)
- Registered address
- 312 EAST VAN BUREN ST., Leesburg, IN 46538
- Contract listings
- 5 device listings, 5 product codes, first listed Jul 2, 1992
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | Class I | General and plastic surgery | Contract manufacturing | Jul 2, 1992 |
| GFF | Bur, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Jul 2, 1992 |
| HTO | Reamer | Class I | Orthopedic | Contract manufacturing | Feb 1, 2013 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | Feb 1, 2013 |
| LYS | Bone Mill | Class I | Orthopedic | Contract manufacturing | Jan 31, 2013 |