Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9613648

FEI Number

3003045637

Entity Name

DANIELS CORPORATION INTERNATIONAL PTY LTD

City/State/Country

Dandenong South Victoria, AU

Establishment Address

Lot 2 Unit 2 533 Frankston- Dandenong Rd, Dandenong South Victoria 3175, AU

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Daniels Corporation International Pty Ltd (Owner Number: 10042527)

Owner / Operator Contact Address

Lot 2 Unit 2 533 Frankston- Dandenong Rd, Dandenong, Melbourne, AU-VIC 3175, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ecoship Bladesafe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MMK	Container, Sharps	General Hospital	Class 2	880.5570	2014-02-13
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2018-03-15

Official Correspondent

Evan Niteros

US Agent Details

Kyle Little Business: Daniels Sharpsmart, Inc Email: klittle@danielshealth.com Phone: (312) 2859087

Related Public Records

Same Entity

Daniels Corporation International Pty Ltd

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 9613648. Last updated year: 2026. Please use registration number 9613648 when referencing this establishment in official correspondence.