Data / Medical devices / United States / Sterizign Precision Technologies
Sterizign Precision Technologies: FDA-registered device maker in Brunswick, ME, United States, 1 510(k) clearance
Sterizign Precision Technologies is registered with the FDA (registration 3014409963) in Brunswick, ME, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 7, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014409963
- Address
- Tech Place 74 Orion Street, Brunswick, ME, United States, 04011
- Owner or operator
- SteriZign Precision Technologies (10057269)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- March 14, 2018
- Registered through
- 2026
- Brand names listed
- MIZ2022-1 EVAN- Evans Rotatable Instrument tray, MIZ2025-1 Single Shaft Bipolar Tray, MIZ2025-2 Adenoma Tray, Standardyz, SteriZign Signatur Device Cassette and Trays, Sterilization Tray, Isto Biologics, miz2022-4 EVAN Evans Rotatable Instrument Tray
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Needle | FSH | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 7, 2018 | K171520 | SteriZign Signatur Device Protection System | KCT | Substantially Equivalent | Sterizign Precision Technologies, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Tray, Surgical, Needle
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Tray, Surgical, Instrument
Updated February 7, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.