FDA Registration
Active
🇺🇸 United States
Steribite, LLC
Reg #: 3009662229
·
FEI: 3009662229
·
Expires 2026
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1
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Registration Details
- Registration Name
- Steribite, LLC
- Registration Number
- 3009662229
- FEI Number
- 3009662229
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1877 Eagle Pass
- City
- Wooster
- State
- OH
- ZIP
- 44691
- Country
- US
Regulatory Submissions
- 510(k) Number
- K180949
Owner / Operator
- Firm Name
- Steribite
- Operator Number
- 10040888
- Address
- 1877 Eagle Pass
- City
- Wooster
- State
- OH
- Postal Code
- 44691
- Country
- US
- Correspondent
- John Redmond
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Rongeur, Manual | HAE | Class 2 | Neurology | No | 2018-12-07 |
Proprietary Names
STERISHARP
STERIBITE
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198