FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106575468
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
03-3641A
Catalog number
03-3641A
Device description
DRESSING CHANGE TRAY
Published
2024-03-15
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
50197106575466PackageGS132In Commercial Distribution
10197106575468PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710657546650197106575466
1019710657546810197106575468

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
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

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
10197106803066CARDINAL HEALTHCardinal Health 200, LLCOXA2024-12-04
50197106803064CARDINAL HEALTHCardinal Health 200, LLCOXA2024-12-04
10197106623497CARDINAL HEALTHCardinal Health 200, LLCOXA2024-04-29
50197106623495CARDINAL HEALTHCardinal Health 200, LLCOXA2024-04-29
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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