Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1823410

FEI Number

1823410

Entity Name

Owens & Minor Distribution Inc. OM44

City/State/Country

Romulus, MI, US

Establishment Address

36663 van Born Rd Ste 390, Romulus, MI 48174, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

O & M Halyard, Inc. (Owner Number: 10039033)

Owner / Operator Contact Address

1220 Old Alpharetta Rd. Ste 320, Alpharetta, GA 30005, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

General Surgery Tray (Kit) SurgiTrack Hip Pack Hand Pack Knee Pack Toe Nail Kit General Convenience Kit General Purpose Kit

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	2015-08-14

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

O & M Halyard, 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
3002669946	Owens & Minor Distribution Inc. OM45	Sunrise, FL, US
3003924117	OWENS & MINOR DISTRIBUTION INC. OM30	Kennesaw, GA, US
1000124971	OWENS & MINOR DISTRIBUTION INC. OM65	Ontario, CA, US
2000028362	OWENS & MINOR DISTRIBUTION INC. OM87	Ashland, VA, US
3011144486	ArcRoyal uc	Kells Meath, IE

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.

Similar Registrations

Registration Number	Establishment Name	Location
3042480961	SURGI-SERVE LLC	Bloomington, IN, US
3002669946	Owens & Minor Distribution Inc. OM45	Sunrise, FL, US
3017430544	CARMAFIL	Martinez, GA, US
3015173212	Medline Industries, LP - Mexicali (MXC)	Mexicali Baja California, MX
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 1823410. Last updated year: 2026. Please use registration number 1823410 when referencing this establishment in official correspondence.