FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956508057
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA11DPSBJ
Catalog number
SBA11DPSBJ
Device description
DIEP PACK
Published
2026-10-12
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
50198956508055PackageGS11In Commercial Distribution
10198956508057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895650805550198956508055
1019895650805710198956508057

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
10198956077348CARDINAL HEALTHSCV57RAKPQSCV57RAKPQ2026-10-12
10198956137547CARDINAL HEALTHPV35VKMBCPV35VKMBC2026-10-12
10198956194632CARDINAL HEALTHSAN33MPMPCSAN33MPMPC2026-10-12
10198956276437CARDINAL HEALTHSOPCNBERVBSOPCNBERVB2026-10-12
10198956301719CARDINAL HEALTHSOP53PKBSCSOP53PKBSC2026-10-12
10198956331259CARDINAL HEALTH32-1024F32-1024F2026-10-12
10198956333611CARDINAL HEALTHPOCGHNWTGPOCGHNWTG2026-10-12
10198956352230CARDINAL HEALTHSAN40SLRWBSAN40SLRWB2026-10-12
10198956361041CARDINAL HEALTHSOP44SPKSCSOP44SPKSC2026-10-12
10198956384439CARDINAL HEALTHSOP32LSISFSOP32LSISF2026-10-12
10198956388376CARDINAL HEALTHSOPCGTHOMESOPCGTHOME2026-10-12
10198956391239CARDINAL HEALTHSOT12CYMOCSOT12CYMOC2026-10-12
10198956399051CARDINAL HEALTHSUT44BPSCBSUT44BPSCB2026-10-12
10198956421240CARDINAL HEALTHSEY23CTRCPSEY23CTRCP2026-10-12
10198956460393CARDINAL HEALTHSEN30EEPRBSEN30EEPRB2026-10-12
10198956463875CARDINAL HEALTH02-0891H02-0891H2026-10-12
10198956471887CARDINAL HEALTHSCV54VCWMUSCV54VCWMU2026-10-12
10198956491298CARDINAL HEALTH31-1019F31-1019F2026-10-12
10198956493803CARDINAL HEALTHSNE11CR83GSNE11CR83G2026-10-12
10198956507425CARDINAL HEALTHSBA42BPSMBSBA42BPSMB2026-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956331259CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956352230CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956399051CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956507425CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956519701CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956523142CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956537491CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956540620CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956542716CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956546110CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956551015CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956553699CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956554689CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956555709CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956558335CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956566699CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956568143CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956568181CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956568662CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956569942CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956570931CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956572195CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956572706CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956580435CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956581128CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956582910CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956584860CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956586772CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956587250CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956589438CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12