FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106803066
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
03-4733A
Catalog number
03-4733A
Device description
DRESSING CHANGE TRAY
Published
2024-12-04
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
OXAMesh, surgical, non-absorbable, thoracic, chest wall reconstruction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OXAMesh, Surgical, Non-Absorbable, Thoracic, Chest Wall ReconstructionGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106803064PackageGS154In Commercial Distribution
10197106803066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710680306450197106803064
1019710680306610197106803066

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 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
10192253004243Monoject31143699311436992026-08-03
10192253004250Monoject31143798311437982026-08-03
10192253004304Monoject31300878313008782026-08-03
20192253050353Vistec659165912023-05-24
10192253004458Monoject85121851212026-07-31
10192253004465Monoject8513018513012026-07-31
10192253004472Monoject85131851312026-07-31
10192253004915Monoject890689062026-07-31
10192253005066Monoject89671896712026-07-31
10192253005295Monoject8990Y8990Y2026-07-31
10192253005516Monoject8535Y8535Y2026-07-31
10192253005622Monoject8970Y8970Y2026-07-31
10197106933145CARDINAL HEALTHPV42CJTMZPV42CJTMZ2026-07-31
10197106950012CARDINAL HEALTHSAN56IPIDFSAN56IPIDF2026-07-31
10198956027596CARDINAL HEALTHSCV73CAHFHSCV73CAHFH2026-07-31
10198956327603CARDINAL HEALTH26-8545D26-8545D2026-07-31
10198956342217CARDINAL HEALTHPB15LHFCLPB15LHFCL2026-07-31
10198956352315CARDINAL HEALTHPW45KFMSAPW45KFMSA2026-07-31
10198956353961CARDINAL HEALTHSNEHBNEECDSNEHBNEECD2026-07-31
10198956364998CARDINAL HEALTHSBADHHMCFDSBADHHMCFD2026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956099838CARDINAL HEALTHCardinal Health 200, LLCOXA2025-06-05
50198956099836CARDINAL HEALTHCardinal Health 200, LLCOXA2025-06-05
50197106803064CARDINAL HEALTHCardinal Health 200, LLCOXA2024-12-04
10197106623497CARDINAL HEALTHCardinal Health 200, LLCOXA2024-04-29
50197106623495CARDINAL HEALTHCardinal Health 200, LLCOXA2024-04-29
10197106575468CARDINAL HEALTHCardinal Health 200, LLCOXA2024-03-15
50197106575466CARDINAL HEALTHCardinal Health 200, LLCOXA2024-03-15
10197106401095CARDINAL HEALTHCardinal Health 200, LLCOXA2023-09-13
50197106401093CARDINAL HEALTHCardinal Health 200, LLCOXA2023-09-13
10195594693763CARDINAL HEALTHCardinal Health 200, LLCOXA2022-07-26
50195594693761CARDINAL HEALTHCardinal Health 200, LLCOXA2022-07-26
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