FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956466302
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA33BCMOB
Catalog number
SBA33BCMOB
Device description
BASIC CORE PACK
Published
2026-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LROGeneral surgery tray

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956466300PackageGS13In Commercial Distribution
10198956466302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895646630050198956466300
1019895646630210198956466302

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 Temperature00

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956078789CARDINAL HEALTHSBACGTPILESBACGTPILE2026-06-05
10198956231061CARDINAL HEALTHSMA45CSHMCSMA45CSHMC2026-06-05
10198956266063CARDINAL HEALTHSEN32MHRMJSEN32MHRMJ2026-06-05
10198956286665CARDINAL HEALTHPOV2SH01YPOV2SH01Y2026-06-05
10198956305274CARDINAL HEALTHSOP21BPWCBSOP21BPWCB2026-06-05
10198956305861CARDINAL HEALTHSBA30HYCRGSBA30HYCRG2026-06-05
10198956321557CARDINAL HEALTHPVHDMJVCOPVHDMJVCO2026-06-05
10198956330085CARDINAL HEALTHPV13OPEMIPV13OPEMI2026-06-05
10198956332522CARDINAL HEALTHSNE24CRNOOSNE24CRNOO2026-06-05
10198956339231CARDINAL HEALTHSCV22EPSBDSCV22EPSBD2026-06-05
10198956339392CARDINAL HEALTHSBA21BLDCCSBA21BLDCC2026-06-05
10198956344471CARDINAL HEALTHPB4AGYHAFPB4AGYHAF2026-06-05
10198956345928CARDINAL HEALTHSOPOCCAHSCSOPOCCAHSC2026-06-05
10198956349261CARDINAL HEALTHSBA40TRCFESBA40TRCFE2026-06-05
10198956353268CARDINAL HEALTHSCV29SPMMCSCV29SPMMC2026-06-05
10198956354241CARDINAL HEALTHSEN4LHNGRESEN4LHNGRE2026-06-05
10198956359963CARDINAL HEALTHSOP56THIDFSOP56THIDF2026-06-05
10198956364905CARDINAL HEALTHSOP5TKASCFSOP5TKASCF2026-06-05
10198956365902CARDINAL HEALTHSBA22BSSTDSBA22BSSTD2026-06-05
10198956367630CARDINAL HEALTHSOT69CYUSESOT69CYUSE2026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956078789CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956266063CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956305861CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956349261CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956354241CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956365902CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956369900CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956377240CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956383081CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956385993CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956386266CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956391598CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956414426CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956439313CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956445079CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956446694CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956453784CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956460409CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956470415CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956470422CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956473126CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956473232CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956475304CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956475335CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956475359CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956476622CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956477704CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956477766CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956477889CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956478367CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05