Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1018120

FEI Number

1018120

Entity Name

Cardinal Health

City/State/Country

AUGUSTA, GA, US

Establishment Address

1430 Marvin Griffin Rd, AUGUSTA, GA 30906, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Cardinal Health 200, LLC (Owner Number: 9028292)

Owner / Operator Contact Address

3651 Birchwood Drive, --, Waukegan, IL 60085, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K973619

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFQ	Gauze/Sponge, Internal	Unknown	Class U	N/A	2008-01-10
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2005-07-11
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2013-05-03
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	1999-08-04
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2009-05-19
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2001-08-22
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2006-03-20
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2021-11-29
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2001-07-26
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2008-01-10
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2007-04-26
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	1999-08-04
KMF	Bandage, Liquid	General Hospital	Class 1	880.5090	2008-01-10
KMF	Bandage, Liquid	General Hospital	Class 1	880.5090	2008-01-10
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2010-08-25
KOX	Solvent, Adhesive Tape	General, Plastic Surgery	Class 1	878.4730	2004-04-07
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2001-07-27
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2014-01-23
KMF	Bandage, Liquid	General Hospital	Class 1	880.5090	2008-01-10

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Cardinal Health 200, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004839227	Cardinal Health Malta 212 Ltd	Marsa, MT
3015541720	Cardinal Health Germany Manufacturing GmbH	Halberstadt Saxony-Anhalt, DE
1033903	Cardinal Health	Greenwood, SC, US
9611018	Cardinal Health Ireland Manufacturing Limited	TULLAMORE Offaly, IE
8040459	Kendall-Gammatron Limited	SAMPRAN Nakhon Pathom, TH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K861444	Surgical Specialties, Inc.	S1 NASAL PACKING	1986-05-06
K863737	Hermitage Hospital Products, Inc.	SPONGES STERILE TWIN PAKT AND SINGLES	1986-10-14
K940351	Certified Safety Mfg., Inc.	EXTRA LARGE COMPRESS DRESSING	1994-02-25
K950404	Lockett Medical Corp.	LOCKETT MEDICAL CORP. GAUZE	1995-04-17
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1018120. Last updated year: 2026. Please use registration number 1018120 when referencing this establishment in official correspondence.