FDA Registration
Active
🇺🇸 United States
ISOMEDIX OPERATIONS INC.
Reg #: 1047843
·
FEI: 1047843
·
Expires 2025
Products
9
Proprietary Names
0
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- ISOMEDIX OPERATIONS INC.
- Registration Number
- 1047843
- FEI Number
- 1047843
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2072 SOUTHPORT RD., HWY. 295
- City
- SPARTANBURG
- State
- SC
- ZIP
- 29306
- Country
- US
Regulatory Submissions
- 510(k) Number
- K210574
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 | 2022-11-24 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2022-11-24 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2022-11-24 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2022-11-24 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2022-11-24 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2022-11-24 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2022-11-24 |
| Neurosurgical Nerve Locator | PDQ | Class 2 | Ear, Nose, Throat | No | 2022-11-24 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2022-11-24 |
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)