FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106932759
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
39-6118B
Catalog number
39-6118B
Device description
SKIN PREP TRAY
Published
2025-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
50197106932757PackageGS112In Commercial Distribution
10197106932759PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710693275750197106932757
1019710693275910197106932759

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 Temperature040 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253004205Monoject1525SA1525SA2026-07-13
10192253004410Monoject8507MW8507MW2026-07-13
10192253004540Monoject8533SA8533SA2026-07-13
10192253004588Monoject8537MW8537MW2026-07-13
10192253004625SharpSafety8540SA8540SA2026-07-13
10192253004885Monoject8900MW8900MW2026-07-13
10192253005127Monoject8979MW8979MW2026-07-13
10192253005509Monoject8525Y8525Y2026-07-13
10192253071894Argyle47802478022026-07-13
20192253017455Kendall31469219314692192021-05-05
20192253017547Medi-Trace Cadence22550A22550A-2021-07-28
20192253017554Medi-Trace Cadence22550P22550P-2021-08-19
20192253017578Medi-Trace Cadence22550PC22550PC2021-07-29
20192253017585Medi-Trace Cadence22550R22550R-2021-07-29
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
20192253017622Medi-Trace Cadence22770P22770P2021-08-19
20192253017639Medi-Trace Cadence22770PC22770PC2021-07-29
20192253017721Kendall31319281313192812021-05-05
20192253018889Medi-Trace Cadence22770R22770R-2021-07-29
20192253017592Medi-Trace Cadence22660PC22660PC2021-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10195327428433Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-12-21
10195327435981Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-08-20
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
10195327440282Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-07-23
10195327437534Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-25
10195327439620Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-25
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