Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009203853

FEI Number

3009203853

Entity Name

GRI-Alleset, Inc.

City/State/Country

Flowery Branch, GA, US

Establishment Address

4142 INDUSTRY WAY, Flowery Branch, GA 30542, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Alleset, Inc. (Owner Number: 10040018)

Owner / Operator Contact Address

4142 INDUSTRy Way, Flowery Branch, GA 30542, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Halyard

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	2020-09-15
LRS	I.V. Start Kit	General Hospital	Class 2	880.5200	2024-08-12
PWL	Oral Surgery Tray	Dental	Class 1	872.4565	2022-04-21
OFQ	Anesthesia Kit	Anesthesiology	Class 2	868.5120	2020-09-15
OXQ	Dressing Change Tray	General Hospital	Class 1	880.5075	2024-01-11
OJU	Skin Prep Tray	General, Plastic Surgery	Class 1	878.4800	2024-08-12
PYB	Minor Surgical Procedures Tray	General, Plastic Surgery	Class 1	878.4800	2024-09-29

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Alleset, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004911384	GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD.	JIAXING Zhejiang, CN

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

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.

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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 3009203853. Last updated year: 2026. Please use registration number 3009203853 when referencing this establishment in official correspondence.