STERIZIGN PRECISION TECHNOLOGIES

FDA Device Registration & Listing · Brunswick, ME, US · Registration 3014409963

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014409963
FEI Number
3014409963
Entity Name
STERIZIGN PRECISION TECHNOLOGIES
City/State/Country
Brunswick, ME, US
Establishment Address
Tech Place 74 Orion Street, Brunswick, ME 04011, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
SteriZign Precision Technologies (Owner Number: 10057269)
Owner / Operator Contact Address
Tech Place 74 Orion Street, Brunswick, ME 04011, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K171520
PMA Number
N/A

All Registered Proprietary Names

MIZ2022-1 EVAN- Evans Rotatable Instrument tray MIZ2025-2 Adenoma Tray miz2022-4 EVAN Evans Rotatable Instrument Tray MIZ2025-1 Single Shaft Bipolar Tray SteriZign Signatur Device Cassette and Trays Sterilization Tray, Isto Biologics

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2025-07-18
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2018-03-14

Official Correspondent

Sonia Lutarewych

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SteriZign Precision Technologies
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K243425 Talladium España, SL Guided DAS Surgical Kit 2025-07-22
K213209 K1 Medical, LLC EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device 2021-12-28
K012105 Symmetry Medical, Inc. POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM 2002-08-02
K243317 Infinitum Eta, Ltd. NUVENTUS NV.C™ Surgical Cassette and Tray 2025-02-11
K112536 Covidien SONICISION STERILIZATION TRAY 2012-04-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2016 Zimmer, Inc. 1
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

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3001397320 ROECHLING MEDICAL ROCHESTER L.P. Rochester, NY, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014409963. Last updated year: 2026. Please use registration number 3014409963 when referencing this establishment in official correspondence.
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