OCULUS SURGICAL INC

FDA Device Registration & Listing · Port St Lucie, FL, US · Registration 3009773841

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
3009773841
FEI Number
3009773841
Entity Name
OCULUS SURGICAL INC
City/State/Country
Port St Lucie, FL, US
Establishment Address
9850 SW Discovery Way, Port St Lucie, FL 34987, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Oculus Surgical Inc (Owner Number: 10042000)
Owner / Operator Contact Address
9850 SW Discovery Way, Port St Lucie, FL 34987, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Tray, Surgical, Instrument SUPER VIEW® Lens Set, Disposable SUPER VIEW® Lens Set, Disposable, Pivot Plus SUPER VIEW® Lens, Disp. Contact, Hassan-Tornambe SUPER VIEW® Lens Set, Disposable HD Plus, for RESIGHT Contact Lens, HD Professional, Cohen-Benner Contact "CBC" SUPER VIEW® Tornambe Contact Lens

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 2019-03-05
HJK Lens, Contact, Polymethylmethacrylate, Diagnostic Ophthalmic Class 2 886.1385 2018-12-20
HNI Retractor, Ophthalmic Ophthalmic Class 1 886.4350 2020-12-11

Official Correspondent

Michael Krakowiecki

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Oculus Surgical Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009773841. Last updated year: 2026. Please use registration number 3009773841 when referencing this establishment in official correspondence.
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