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
20885380173544Curity9022G9022G2019-11-14
20885380173568Curity9024G9024G2019-11-14
10198956038127CARDINAL HEALTHSAN22IAMRASAN22IAMRA2026-10-19
10198956180000CARDINAL HEALTHPUV2KPMHBPUV2KPMHB2026-10-19
10198956268111CARDINAL HEALTHSNECGACSGESNECGACSGE2026-10-19
10198956377967CARDINAL HEALTHSBA56MIMCFSBA56MIMCF2026-10-19
10198956384774CARDINAL HEALTHSVA42LVGLCSVA42LVGLC2026-10-19
10198956390799CARDINAL HEALTHSEYCGEPAZBSEYCGEPAZB2026-10-19
10198956400795CARDINAL HEALTHSOP3MKPCVDSOP3MKPCVD2026-10-19
10198956414815CARDINAL HEALTHSMA41PGEPBSMA41PGEPB2026-10-19
10198956441811CARDINAL HEALTHSCV29VPPCUSCV29VPPCU2026-10-19
10198956462328CARDINAL HEALTHSCV13PPBTESCV13PPBTE2026-10-19
10198956464988CARDINAL HEALTHSOP51XRKKPSOP51XRKKP2026-10-19
10198956499270CARDINAL HEALTHPG33BGMKBPG33BGMKB2026-10-19
10198956499980CARDINAL HEALTH33-2528E33-2528E2026-10-19
10198956506732CARDINAL HEALTHSOP41TPDSFSOP41TPDSF2026-10-19
10198956513587CARDINAL HEALTHSAN33CACHNSAN33CACHN2026-10-19
10198956514874CARDINAL HEALTHSOPOCTKSBBSOPOCTKSBB2026-10-19
10198956516922CARDINAL HEALTHPC23TAAMEPC23TAAME2026-10-19
10198956518964CARDINAL HEALTHSAN40CCAEGSAN40CCAEG2026-10-19

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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