Contract manufacturerRED STAR CONTRACT MANUFACTURING INC. (Larwill, IN)IndianaGeneral and plastic surgeryOrthopedicEar, nose and throatClass IIClass I
RED STAR CONTRACT MANUFACTURING INC.
Contract manufacturer ยท Larwill, IN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3009631939 (openFDA record; or search FDA's registration database)
- FEI number
- 3009631939
- Registered for
- FDA registration year 2026
- Establishment types
- Complaint file establishment; Specification developer; Manufacturer; Contract manufacturer; Repackager or relabeler
- Owner or operator
- Red Star Contract Manufacturing (FDA owner/operator no. 10046073)
- Registered address
- 1560 N State Road 5, Larwill, IN 46764
- Contract listings
- 12 device listings, 12 product codes, first listed May 14, 2021
- 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 |
|---|---|---|---|---|---|
| FTD | Lamp, Surgical | Class II | General and plastic surgery | Contract manufacturing | May 14, 2021 |
| FTY | Tape, Measuring, Rulers And Calipers | Class I | General and plastic surgery | Contract manufacturing | Sep 28, 2022 |
| FZX | Guide, Surgical, Instrument | Class I | General and plastic surgery | Contract manufacturing | Sep 28, 2022 |
| HTW | Bit, Drill | Class I | Orthopedic | Contract manufacturing | May 14, 2021 |
| HTY | Pin, Fixation, Smooth | Class II | Orthopedic | Contract manufacturing | May 14, 2021 |
| HWB | Extractor | Class I | Orthopedic | Contract manufacturing | May 14, 2021 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Mar 5, 2026 |
| HWT | Template | Class I | Orthopedic | Contract manufacturing | Sep 28, 2022 |
| HXX | Screwdriver | Class I | Orthopedic | Contract manufacturing | Sep 28, 2022 |
| JDR | Staple, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Oct 31, 2023 |
| JYQ | Loop, Wire | Class I | Ear, nose and throat | Contract manufacturing | Dec 17, 2025 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | May 14, 2021 |