FDA Registration
Active
🇺🇸 United States
MTS225 GETINGE Cabinet
Reg #: 3012085539
·
FEI: 3012085539
·
Expires 2025
Products
1
Proprietary Names
21
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- SterCUBE Surgical Systems, LLC
- Registration Number
- 3012085539
- FEI Number
- 3012085539
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1452 Hughes Rd Ste 200, Pmb 550
- City
- Grapevine
- State
- TX
- ZIP
- 76051
- Country
- US
Regulatory Submissions
- 510(k) Number
- K152014
Owner / Operator
- Firm Name
- SteriCUBE Surgical Systems, LLC
- Operator Number
- 10050671
- Address
- 1452 Hughes Road, Suite 200, PMB #550
- City
- Grapevine
- State
- TX
- Postal Code
- 76051
- Country
- US
- Correspondent
- Lisa J Holt
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2015-12-14 |
Proprietary Names
MTS225 GETINGE Cabinet
MTS300 Filter Kit
MTS300 Transfer Cart, Getinge
STERIS Evolution Bridge
STERIS Bridge
MTS300 Transfer Cart, Steris, Standard
MTS300 Cabinet, Getinge
MTS300 Transfer Cart, FL, Universal
MTS225 Cabinet
MTS225 STERIS Transfer Cart
SteriCUBE Filter Kit Plus
MTS225 Cabinet, Steris 600
MTS Filter Kit
MTS225 GETINGE Transfer Cart
MTS300 Cabinet, Steris, Evolution
MTS300 Cabinet, Steris, Standard
MTS300 Transfer Cart, Steris, Evolution
MTS300 Floor Loader, Getinge
MTS225 TCFL Transfer Cart
MTS225 Transfer Cart, Steris 600
GETINGE Bridge
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198