FDA Registration
Active
🇺🇸 United States
STERILMED, INC.
Reg #: 3011276773
·
FEI: 3011276773
·
Expires 2026
Products
8
Proprietary Names
10
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- STERILMED, INC.
- Registration Number
- 3011276773
- FEI Number
- 3011276773
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5010 Cheshire Pkwy N Ste 2
- City
- Plymouth
- State
- MN
- ZIP
- 55446
- Country
- US
Regulatory Submissions
- 510(k) Number
- K110076
Owner / Operator
- Firm Name
- STERILMED, INC.
- Operator Number
- 9030419
- Address
- 5010 Cheshire Parkway N, Suite 2
- City
- Plymouth
- State
- MN
- Postal Code
- 55446
- Country
- US
- Correspondent
- Robert Macnamara
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reprocessed Intravascular Ultrasound Catheter | OWQ | Class 2 | Cardiovascular | No | 2011-11-15 |
| Catheter, Recording, Electrode, Reprocessed | NLH | Class 2 | Cardiovascular | No | 2016-06-23 |
| Catheter, Intracardiac Mapping, High-Density, Reprocessed | NLG | Class 2 | Cardiovascular | No | 2021-08-13 |
| Catheter, Intracardiac Mapping, High-Density Array | MTD | Class 2 | Cardiovascular | No | 2021-08-13 |
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | Class 2 | Cardiovascular | No | 2024-10-30 |
| Reprocessed Bronchoscope | QNW | Class 2 | Ear, Nose, Throat | No | 2024-01-04 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2009-10-26 |
| Software For Diagnosis/Treatment | OSN | Class 2 | Orthopedic | No | 2019-10-28 |
Proprietary Names
Reprocessed Ultrasound Catheter
Reprocessed Imaging Catheter
Reprocessed Lasso Nav eco and Reprocessed Lasso 2515 Nav eco Variable Electrophysiology (EP) Catheters
Reprocessed EP Catheters
Reprocessed EP Catheter
Reprocessed DECANAV Electrophysiology Catheter
EP Catheter
Reprocessed External Fixation Device
MAXFRAME
Reprocessed ultrasound catheter
Establishment Types
Reprocess Single-Use Device
Develop Specifications But Do Not Manufacture At This Facility