FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10885425254583
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA13LPMRU
Catalog number
SBA13LPMRU
Device description
STERILE MAJOR ABDOMINAL PACK
Published
2016-07-14
Public version status
Update
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
LROGeneral surgery tray (kit)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885425254581PackageGS11In Commercial Distribution
10885425254583PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088542525458150885425254581
1088542525458310885425254583

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, 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.

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
10198956182004CARDINAL HEALTHSOPCNEPBSFSOPCNEPBSF2026-07-06
10198956202320CARDINAL HEALTH34-9397L34-9397L2026-07-06
10198956261952CARDINAL HEALTH08-1780F08-1780F2026-07-06
10198956331235CARDINAL HEALTH32-7479R32-7479R2026-07-06
10198956358942CARDINAL HEALTHSEN4LTAGRCSEN4LTAGRC2026-07-06
10198956373068CARDINAL HEALTHSOP53HIOHCSOP53HIOHC2026-07-06
10198956373655CARDINAL HEALTHSANCGANMWCSANCGANMWC2026-07-06
10198956380615CARDINAL HEALTHENDDK4659DENDDK4659D2026-07-06
10198956381124CARDINAL HEALTH34-0950C34-0950C2026-07-06
10198956388789CARDINAL HEALTHSMA11DCWNFSMA11DCWNF2026-07-06
10198956389007CARDINAL HEALTHSEN35ENCFDSEN35ENCFD2026-07-06
10198956393424CARDINAL HEALTHSBADHLPNVCSBADHLPNVC2026-07-06
10198956397361CARDINAL HEALTHSAN29MY87ISAN29MY87I2026-07-06
10198956398689CARDINAL HEALTHSAN3MARCVCSAN3MARCVC2026-07-06
10198956407053CARDINAL HEALTHSOP69TJMSBSOP69TJMSB2026-07-06
10198956414693CARDINAL HEALTHSOP48TKLODSOP48TKLOD2026-07-06
10198956416079CARDINAL HEALTHPN11SF36DPN11SF36D2026-07-06
10198956416482CARDINAL HEALTHSAN11CC26CSAN11CC26C2026-07-06
10198956423077CARDINAL HEALTHPBCGDCBLIPBCGDCBLI2026-07-06
10198956427198CARDINAL HEALTHSBA13SMBTBSBA13SMBTB2026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956261952CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956331235CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956393424CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956427198CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956445864CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956456969CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956473072CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956477209CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956487161CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956493773CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956494619CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956497443CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956498440CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956498747CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956499553CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956502765CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956504059CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956504127CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956504820CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956508897CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956509221CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956510081CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956515505CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956524576CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956525122CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956525351CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956525719CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956525825CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956525924CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10809160526156HALYARDAVID MEDICAL, INC.LRO2026-07-06