Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1054380

FEI Number

1000110722

Entity Name

Halyard North Carolina, LLC

City/State/Country

LINWOOD, NC, US

Establishment Address

389 CLYDE FITZGERALD RD, LINWOOD, NC 27299, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

O&M Halyard, Inc. (Owner Number: 10057479)

Owner / Operator Contact Address

1220 Old Alpharetta Rd, Suite 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

STERILIZATION WRAP STERILIZATION WRAP STERILIZATION WRAP HALYARD® SEQUENTIAL Sterilization Wrap HALYARD® ONE-STEP® Sterilization Wrap HALYARD® QUICK CHECK® Sterilization Wrap HALYARD® SMART-FOLD® Sterilization Wrap STERILIZATION WRAP STERILIZATION WRAP STERILIZATION WRAP STERILIZATION WRAP STERILIZATION WRAP STERILIZATION WRAP STERILIZATION WRAP Halyard ONE-STEP Sterilization Wrap EXAMINATION GOWN STERILIZATION WRAP STERILIZATION WRAP HALYARD PROCEDURE GOWN

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2018-05-02
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2018-05-02
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2018-05-02
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2024-09-26
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2018-06-20
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2018-05-02
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2018-05-02
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2018-05-02
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2018-06-20
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2018-05-02
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2018-05-02
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2020-01-09
FME	Gown, Examination	General Hospital	Class 1	880.6265	2018-05-02
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2018-05-02
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2018-05-02
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2018-05-18

Official Correspondent

Angela Bunn

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
3012143814	Southaven Distribution Center	Southaven, MS, US
3016849443	O&M Halyard, Inc. (La Ada de Acuna)	Del Rio, TX, US
9680646	O&M Halyard Honduras S.A de C.V.	VILLANEVA Cortes, HN
3035642068	Honduras Kitting, S.A.	Villanueva Cortes, HN
3005997949	La Ada De Acuna, S. de. R. L. de C. V.	COL.EDUCATIVA,NOGALES Sonora, MX

Similar Registrations

Registration Number	Establishment Name	Location
2523664	M & Q PACKAGING LLC	SCHUYLKILL HAVEN, PA, US
9680031	STEPAC L.A., LTD.	TEFEN, WESTERN GALILEE Northern, IL
9616096	La Ada de Acuna	CIUDAD DE ACUNA Coahuila, MX
8030674	ESPECIALISTAS EN ESTERILIZACION Y ENVASE, S. A. DE C. V.	Tlalnepantla, Estado de Mexico, MX
3004193466	HU-FRIEDY MFG.CO. LLC ZWEIGNIEDERLASSUNG DEUTSC	Emmingen-Liptingen Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1054380. Last updated year: 2026. Please use registration number 1054380 when referencing this establishment in official correspondence.