Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011144486

FEI Number

3011144486

Entity Name

ArcRoyal uc

City/State/Country

Kells Meath, IE

Establishment Address

Virginia Road, Kells Meath A82 R862, IE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

Cardiovascular Procedure Kit Obstetrical Kit Eye Kit Cardiac Catheterization Kit 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
OEZ	Cardiovascular Procedure Kit	Cardiovascular	Class 2	870.1200	2016-03-17
OKV	Obstetrical Kit	Obstetrics/Gynecology	Class 2	884.4520	2015-08-20
OJK	Eye Tray	Ophthalmic	Class 2	886.4790	2015-08-14
OES	Cardiac Catheterization Kit	Cardiovascular	Class 2	870.1200	2016-06-22
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2015-08-14

Official Correspondent

Angela Bunn

US Agent Details

Angela Bunn Business: O&M HALYARD, INC. Email: angela.bunn@owens-minor.com Phone: (770) 4011697

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
3010376936	Owens & Minor Distribution Inc. OM41	Flower Mound, TX, US

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-0490-2025	Alcon Research LLC	2	a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing TUBING, SALEM SUMP, 18 FR; c) VITRECTOMY ILLINOIS MASONIC MED CTR, # 9456-59, # 9456-60, and # 9456-61 each containing TUBING, SALEM SUMP, 18 FR; d) VITRECTOMY MCGEE EYE SURG CTR, # 12216-12, # 12216-14, and # 12216-15, each containing TUBING, SALEM SUMP, 14 FR.
Z-0027-2020	Merit Medical Systems, Inc.	2	Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580
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.

Similar Registrations

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3002807314	Synergy Health Ireland Ltd	Tullamore Offaly, IE
1047429	AVID MEDICAL, INC. A MEDICAL ACTION IND. COMPANY 305	TOANO, VA, US
3009888344	Isomedix Operations Inc	El Paso, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011144486. Last updated year: 2026. Please use registration number 3011144486 when referencing this establishment in official correspondence.