FDA Registration
Active
🇺🇸 United States
X-Change Cement Dispensing Syringe
Reg #: 1724474
·
FEI: 3003094851
·
Expires 2025
Products
1
Proprietary Names
8
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
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 |
|---|---|---|---|---|---|
| Injector, Vertebroplasty (Does Not Contain Cement) | OAR | Class 1 | Orthopedic | No | 2016-01-28 |
Proprietary Names
X-Change Cement Dispensing Syringe
Hydraulic-Master Syringe Assembly
Osseoflex Bone Filler Device (BFD)
Purge Assist
Hydraulic Assembly
StabiliT Cement Delivery Syringe
DiamondTouch Syringe
Master Syringe Assembly
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)