FDA Registration
Active
🇺🇸 United States
RUMI System [Mfg]
Reg #: 1627186
·
FEI: 1627186
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Lone Star Medical Products
- Registration Number
- 1627186
- FEI Number
- 1627186
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 11211 Cash Rd
- City
- Stafford
- State
- TX
- ZIP
- 77477
- Country
- US
Regulatory Submissions
- 510(k) Number
- K932115
Owner / Operator
- Firm Name
- COOPERSURGICAL, INC.
- Operator Number
- 9002384
- Address
- 95 CORPORATE DR., --
- City
- Trumbull
- State
- CT
- Postal Code
- 06611
- Country
- US
- Correspondent
- Mauro Castro
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cannula, Manipulator/Injector, Uterine | LKF | Class 2 | Obstetrics/Gynecology | No | 2008-03-17 |
Proprietary Names
RUMI System [Mfg]
RUMI II & RUMI Arch II Handles [SD]
RUMI II & RUMI Arch II Handles [Mfg]
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)