FDA Registration
Active
🇺🇸 United States
Acromioplaty Elecrode
Reg #: 1018470
·
FEI: 1018470
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics U.S., LLC
- Registration Number
- 1018470
- FEI Number
- 1018470
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2971 Olympic Industrial Dr SE Ste 116
- City
- Atlanta
- State
- GA
- ZIP
- 30339
- Country
- US
Regulatory Submissions
- 510(k) Number
- K823424
Owner / Operator
- Firm Name
- Sotera Health LLC
- Operator Number
- 10029425
- Address
- 2015 Spring Road, Suite 650
- City
- Oak Brook
- State
- IL
- Postal Code
- 60523
- Country
- US
- Correspondent
- Karen Whaley-Krumins
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2013-04-29 |
Proprietary Names
Acromioplaty Elecrode
Small Joint Electrode
Soft Tissue Electrode
Meniscectomy Electrode
Concept Ablator Electrode
SOFT TISSUE ELECTRODE, HOOK DESIGN, SHORT, 111MM
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)