Contract manufacturerDONATELLE PLASTICS, LLC (New Brighton, MN)MinnesotaCardiovascularGeneral hospitalOrthopedicGeneral and plastic surgeryClass IIClass IClass III
DONATELLE PLASTICS, LLC
Contract manufacturer ยท New Brighton, MN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3004961578 (openFDA record; or search FDA's registration database)
- FEI number
- 3004961578
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- DONATELLE PLASTICS, LLC (FDA owner/operator no. 9040147)
- Registered address
- 501 COUNTY RD. E-2 EXTENSION, New Brighton, MN 55112
- Contract listings
- 9 device listings, 11 product codes, first listed Sep 14, 2012
- 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 |
|---|---|---|---|---|---|
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | Class II | Cardiovascular | Contract manufacturing | Sep 14, 2012 |
| DWS | Instruments, Surgical, Cardiovascular | Class I | Cardiovascular | Contract manufacturing | Dec 18, 2012 |
| FMI | Needle, Hypodermic, Single Lumen | Class II | General hospital | Contract manufacturing | May 8, 2018 |
| HTY | Pin, Fixation, Smooth | Class II | Orthopedic | Contract manufacturing | Feb 20, 2023 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Feb 20, 2023 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | Contract manufacturing | Nov 24, 2014 |
| LWS | Implantable Cardioverter Defibrillator (Non-Crt) | Class III | Cardiovascular | Contract manufacturing | Oct 24, 2023 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | Feb 20, 2023 |
| NRB | Wound Cleaner, Ultrasound | Class II | General and plastic surgery | Contract manufacturing | May 21, 2026 |
| NVY | Permanent Defibrillator Electrodes | Class III | Cardiovascular | Contract manufacturing | Oct 24, 2023 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Class II | Orthopedic | Contract manufacturing | Mar 20, 2014 |