OM HEALTHCARE LOGISTICS OM03

FDA Device Registration & Listing · Louisville, KY, US · Registration 3008135745

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008135745
FEI Number
3008135745
Entity Name
OM HEALTHCARE LOGISTICS OM03
City/State/Country
Louisville, KY, US
Establishment Address
6201 Global Distribution Way Ste 101, Louisville, KY 40228, 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
N
Expiration Date (Year)
2026
510(k) Number
K142529
PMA Number
N/A

All Registered Proprietary Names

sterilization Wrap

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2022-09-30
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2022-09-30

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
K243425 Talladium España, SL Guided DAS Surgical Kit 2025-07-22
K213209 K1 Medical, LLC EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device 2021-12-28
K012105 Symmetry Medical, Inc. POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM 2002-08-02
K243317 Infinitum Eta, Ltd. NUVENTUS NV.C™ Surgical Cassette and Tray 2025-02-11
K112536 Covidien SONICISION STERILIZATION TRAY 2012-04-19

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3005706667 TURNER MEDICAL INC. Athens, AL, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008135745. Last updated year: 2026. Please use registration number 3008135745 when referencing this establishment in official correspondence.
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