FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956178281
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
11-7005A
Catalog number
11-7005A
Device description
TRAY,SKIN PREP,WET,VAG ABD,ST
Published
2026-01-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OJUSkin prep tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJUSkin Prep TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956178289PackageGS120In Commercial Distribution
10198956178281PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895617828950198956178289
1019895617828110198956178281

GMDN Terms#

Term, Definition table
TermDefinition
Surgical patient preparation kitA collection of devices designed for the preoperative preparation of the operative site on a patient's body. It typically includes scrubbing pads (e.g., surgical sponges) and sterilizing/disinfecting solutions. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253072037CARDINAL HEALTHALMASK5ALMASK52026-07-29
10192253072044CARDINAL HEALTHAMMASK4AMMASK42026-07-29
10192253072051CARDINAL HEALTHAXLMASK6AXLMASK62026-07-29
10192253072068CARDINAL HEALTHCHIMASK3CHIMASK32026-07-29
10192253072075CARDINAL HEALTHINFMASK1INFMASK12026-07-29
10192253072082CARDINAL HEALTHNEOMASK0NEOMASK02026-07-29
10192253072105CARDINAL HEALTHTODMASK2TODMASK22026-07-29
10192253025699Dover888876051688887605162023-11-21
10192253025705Dover888876051888887605182023-11-21
10192253025712Dover888876052088887605202023-11-21
10192253025750Dover888876301888887630182023-11-21
10192253025774Dover888876302288887630222023-11-21
10192253026344Dover35603560-2022-04-12
10192253028201Dover62086208-2024-10-14
10192253030365Dover888849206688884920662025-04-07
10192253031836DoverP4P16ULDP4P16ULD-2024-08-22
10192253068573Dover33053305-2026-01-16
10192253068634Dover61556155-2026-01-16
10197106541029CARDINAL HEALTH01A1360C01A1360C2024-03-06
10197106741030CARDINAL HEALTH03-2242D03-2242D2024-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956442016CARDINAL HEALTHCardinal Health 200, LLCOJU2026-07-20
10198956178298CARDINAL HEALTHCardinal Health 200, LLCOJU2026-01-13
10195327428433Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-12-21
10195327242664Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-07-29
10195327261627Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-07-29
10195327421830Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-07-29
10195327427382Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-07-29
10195327428228Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-07-29
10195327432614Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-07-29
10195327238445Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327267025Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327268046Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327269197Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327272012Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327272555Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327277093Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327277284Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327277925Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327278922Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327279004Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327280567Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327285517Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327285654Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327297602Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327298753Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327340643Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327342722Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327343163Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327343378Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327343590Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13