FDA Registration
Active
🇺🇸 United States
STERIS ISOMEDIX PUERTO RICO, INC.
Reg #: 2648623
·
FEI: 2648623
·
Expires 2025
Products
5
Proprietary Names
0
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- STERIS ISOMEDIX PUERTO RICO, INC.
- Registration Number
- 2648623
- FEI Number
- 2648623
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- KM 1 7, STATE Road, 690, BARRIO SABANA HOYOS
- City
- Alts De Cerro Gordo 3&4
- State
- PR
- ZIP
- 00692
- Country
- US
Regulatory Submissions
- 510(k) Number
- K210637
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 1527821
- Address
- 5960 Heisley Rd, --
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2023-12-19 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2023-12-19 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2023-12-19 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2023-12-19 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2023-12-19 |
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)