FDA Registration
Active
🇺🇸 United States
DONATELLE PLASTICS, LLC
Reg #: 3004961578
·
FEI: 3004961578
·
Expires 2026
Products
11
Proprietary Names
0
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- DONATELLE PLASTICS, LLC
- Registration Number
- 3004961578
- FEI Number
- 3004961578
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 501 COUNTY RD. E-2 EXTENSION
- City
- NEW BRIGHTON
- State
- MN
- ZIP
- 55112
- Country
- US
Owner / Operator
- Firm Name
- DONATELLE PLASTICS, LLC
- Operator Number
- 9040147
- Address
- 501 COUNTY RD. E-2 EXTENSION, --
- City
- New Brighton
- State
- MN
- Postal Code
- 55112
- Country
- US
- Correspondent
- Terry K Bauerly
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2014-03-20 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2023-02-20 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2023-02-20 |
| Implantable Cardioverter Defibrillator (Non-Crt) | LWS | Class 3 | Unknown | No | 2023-10-24 |
| Permanent Defibrillator Electrodes | NVY | Class 3 | Unknown | No | 2023-10-24 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2014-11-24 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2023-02-20 |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | Class 2 | Cardiovascular | No | 2012-09-14 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2012-12-18 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2018-05-08 |
| Wound Cleaner, Ultrasound | NRB | Class 2 | General, Plastic Surgery | No | 2026-05-21 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)