FDA Registration
Active
🇺🇸 United States
E2581-28 Argon Plus Laparoscopic Modified Flat-L Electrode, Retractable, 11"
Reg #: 1724474
·
FEI: 3003094851
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Terumo BCT STERILIZATION SERVICES, Inc.
- Registration Number
- 1724474
- FEI Number
- 3003094851
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 11308 W Collins Ave
- City
- LAKEWOOD
- State
- CO
- ZIP
- 80215
- Country
- US
Regulatory Submissions
- 510(k) Number
- K931028
Owner / Operator
- Firm Name
- Terumo BCT, INC.
- Operator Number
- 9002708
- Address
- 10811 WEST COLLINS AVE., --
- City
- Lakewood
- State
- CO
- Postal Code
- 80215
- Country
- US
- Correspondent
- Corrine Lucas
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2013-02-13 |
Proprietary Names
E2581-28 Argon Plus Laparoscopic Modified Flat-L Electrode, Retractable, 11"
E2580-28 Argon Plus Laparoscopic Blade Electrode, Retractable, 11"
E2583-28 Argon Plus Laparoscopic Tungsten Blunt Needle Electrode, Retractable, 11"
E2582-28 Argon Plus Laparoscopic Tungsten Sharp Needle Electrode, Retractable, 11"
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)