FDA Registration
Active
🇺🇸 United States
Dielectrics, Inc.
Reg #: 1220351
·
FEI: 1220351
·
Expires 2026
Products
9
Proprietary Names
5
Establishment Types
2
Classifications
9
Registration Details
- Registration Name
- Dielectrics, Inc.
- Registration Number
- 1220351
- FEI Number
- 1220351
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 300 BURNETT RD.
- City
- CHICOPEE
- State
- MA
- ZIP
- 01020
- Country
- US
Owner / Operator
- Firm Name
- Dielectrics, Inc.
- Operator Number
- 1220351
- Address
- 300 Burnett Road, --
- City
- Chicopee
- State
- MA
- Postal Code
- 01020
- Country
- US
- Correspondent
- Cheryl - Cormier
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cushion, Flotation | KIC | Class 1 | Physical Medicine | No | 2016-03-17 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2022-08-08 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2016-03-10 |
| Containment System, Laparoscopic Power Morcellation, With Instrument Port | PMU | Class 2 | Obstetrics/Gynecology | No | 2016-10-27 |
| System, Thermal Regulating | DWJ | Class 2 | Cardiovascular | No | 2018-08-21 |
| Tourniquet, Pneumatic | KCY | Class 1 | General, Plastic Surgery | No | 2016-05-26 |
| Laparoscopic Single Port Access Device | OTJ | Class 2 | Gastroenterology, Urology | No | 2013-12-16 |
| Collector, Urine, Powered, Non Indwelling Catheter | NZU | Class 1 | Gastroenterology, Urology | No | 2018-12-11 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2016-03-17 |
Proprietary Names
SofCare Chair Cushion
PneumoLiner
Altrix Wrap
Safeguard Pressure Assisted Dressing (12cm)
SofCare HeelCare Boot
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device