Contract manufacturerPTI Engineered Plastics (Macomb, MI)MichiganGastroenterology and urologyGeneral and plastic surgeryGeneral hospitalClass I
PTI Engineered Plastics
Contract manufacturer · Macomb, MI
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3007238674 (openFDA record; or search FDA's registration database)
- FEI number
- 3007238674
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- PTI Engineered Plastics (FDA owner/operator no. 10022700)
- Registered address
- 50900 Corporate Drive, Macomb, MI 48044
- Contract listings
- 3 device listings, 3 product codes, first listed Oct 10, 2007
- 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 |
|---|---|---|---|---|---|
| FGX | Snare, Non-Electrical | Class I | Gastroenterology and urology | Contract manufacturing | Oct 10, 2007 |
| FZX | Guide, Surgical, Instrument | Class I | General and plastic surgery | Contract manufacturing | Jan 17, 2024 |
| KMI | Monitor, Bed Patient | Class I | General hospital | Contract manufacturing | Oct 10, 2007 |