Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010166880

FEI Number

3010166880

Entity Name

LEESAR, INC.

City/State/Country

Fort Myers, FL, US

Establishment Address

2727 Winkler Ave, Fort Myers, FL 33901, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Leesar, Inc. (Owner Number: 10048820)

Owner / Operator Contact Address

2727 Winkler Avenue, Fort Myers, FL 33901, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CODETRAYS ORMTRAY EPITRAY PAINMEDTRAY PEDMEDTRAY OBLABOR AUXILIARY CARTKITS ALS BLS PEDIATRIC INFUSION AIRWAY

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2015-03-06
MLS	Labor And Delivery Kit	Obstetrics/Gynecology	Class 2	884.4530	2015-03-06
OVR	Kit, First Aid, Talking	General, Plastic Surgery	Class 1	878.4014	2025-12-02
ENW	Catheter, Nasopharyngeal	Ear, Nose, Throat	Class 1	874.4175	2025-12-02

Official Correspondent

Julia Robinson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Leesar, Inc.

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
K961683	J.J. Skinner, Inc.	JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY	1996-05-10
K936120	Cush Medical Products	LABOR AND DELIVERY TRAY	1994-03-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0028-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0030-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0031-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0095-2021	Alcon Research, LLC	2	Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.

Similar Registrations

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3007007790	Sterigenics Shanghai ETO Ltd.	Shanghai, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010166880. Last updated year: 2026. Please use registration number 3010166880 when referencing this establishment in official correspondence.