Contract manufacturerREVELATION MEDICAL DEVICES, LLC (Auburn, IN)IndianaGeneral and plastic surgeryOrthopedicClass IClass II
REVELATION MEDICAL DEVICES, LLC
Contract manufacturer · Auburn, IN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1836116 (openFDA record; or search FDA's registration database)
- FEI number
- 3002687954
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer; Remanufacturer
- Owner or operator
- REVELATION MEDICAL DEVICES LLC (FDA owner/operator no. 10051413)
- Registered address
- 1105 West Auburn Street, Auburn, IN 46706
- Contract listings
- 9 device listings, 9 product codes, first listed Mar 15, 2016
- 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 |
|---|---|---|---|---|---|
| GAD | Retractor | Class I | General and plastic surgery | Contract manufacturing | Dec 19, 2024 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Class II | Orthopedic | Contract manufacturing | Sep 19, 2023 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Class II | Orthopedic | Contract manufacturing | Sep 19, 2023 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | Class II | Orthopedic | Contract manufacturing | Sep 19, 2023 |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | Class II | Orthopedic | Contract manufacturing | Sep 19, 2023 |
| MDM | Instrument, Manual, Surgical, General Use | Class I | General and plastic surgery | Contract manufacturing | Mar 15, 2016 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | Contract manufacturing | Aug 1, 2023 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Class II | Orthopedic | Contract manufacturing | Sep 19, 2023 |
| PKC | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | Class II | Orthopedic | Contract manufacturing | Sep 19, 2023 |