FDA Registration
Active
🇺🇸 United States
SteriZign Signatur Device Cassette and Trays
Reg #: 3014409963
·
FEI: 3014409963
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- STERIZIGN PRECISION TECHNOLOGIES
- Registration Number
- 3014409963
- FEI Number
- 3014409963
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Tech Place 74 Orion Street
- City
- Brunswick
- State
- ME
- ZIP
- 04011
- Country
- US
Regulatory Submissions
- 510(k) Number
- K171520
Owner / Operator
- Firm Name
- SteriZign Precision Technologies
- Operator Number
- 10057269
- Address
- Tech Place 74 Orion Street
- City
- Brunswick
- State
- ME
- Postal Code
- 04011
- Country
- US
- Correspondent
- Sonia Lutarewych
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2018-03-14 |
Proprietary Names
SteriZign Signatur Device Cassette and Trays
Sterilization Tray, Isto Biologics
Establishment Types
Manufacture Medical Device