Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3036002406

FEI Number

3036002406

Entity Name

OWENS & MINOR DISTRIBUTION INC.OM05

City/State/Country

Morgantown, WV, US

Establishment Address

78 Pipe Street, Morgantown, WV 26501, 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

SurgiTrack Instrument Tray Liner Surgical Tray 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
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2014-03-06
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
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06
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-0036-2010	Alphatec Spine, Inc.	1	ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
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.

Similar Registrations

Registration Number	Establishment Name	Location
3002669946	Owens & Minor Distribution Inc. OM45	Sunrise, FL, US
1646747	WEXLER SURGICAL, INC.	HOUSTON, TX, US
1037577	ANGIOSYSTEMS, INC.	DUCKTOWN, TN, US
3016171961	HANGZHOU ALLINE PLASTIC CO., LTD.	HANGZHOU Zhejiang, CN
3007485169	MEDYSSEY CO., LTD.	Jecheon-si Chungbuk, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3036002406. Last updated year: 2026. Please use registration number 3036002406 when referencing this establishment in official correspondence.