FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50888439851920
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA51MJUST
Catalog number
SBA51MJUST
Device description
MAJOR PACK
Published
2020-09-08
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
50888439851920PackageGS12In Commercial Distribution
10888439851922PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843985192050888439851920
1088843985192210888439851922

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

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
10198956448025CARDINAL HEALTH11-9002NSC11-9002NSC2026-10-15
10198956531666CARDINAL HEALTH03L2276A03L2276A2026-10-15
10198956538030CARDINAL HEALTHSOP48KASUFSOP48KASUF2026-10-15
10198956542075CARDINAL HEALTH34-8052I34-8052I2026-10-15
10198956543577CARDINAL HEALTHSNE21CRCAHSNE21CRCAH2026-10-15
10198956544017CARDINAL HEALTHSMA54RPUPFSMA54RPUPF2026-10-15
10198956546424CARDINAL HEALTHSOP53SAFOHSOP53SAFOH2026-10-15
10198956549760CARDINAL HEALTHSUT11BAMMCSUT11BAMMC2026-10-15
10198956555211CARDINAL HEALTHSOP43KAIBDSOP43KAIBD2026-10-15
10198956560765CARDINAL HEALTHSAN54SMPTDSAN54SMPTD2026-10-15
10198956561311CARDINAL HEALTHPO54PSJHCPO54PSJHC2026-10-15
10198956562523CARDINAL HEALTH34-9491A34-9491A2026-10-15
10198956563056CARDINAL HEALTH34B0820I34B0820I2026-10-15
10198956565388CARDINAL HEALTHPUMHPY12APUMHPY12A2026-10-15
10198956565470CARDINAL HEALTH03-2757O03-2757O2026-10-15
10198956565883CARDINAL HEALTH34-2121F34-2121F2026-10-15
10198956566613CARDINAL HEALTHSBA53BPPNDSBA53BPPND2026-10-15
10198956568969CARDINAL HEALTH34-9232B34-9232B2026-10-15
10198956569416CARDINAL HEALTHSOT48VYIWBSOT48VYIWB2026-10-15
10198956569966CARDINAL HEALTH07-8497A07-8497A2026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956544017CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956549760CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956560765CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956566613CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956569966CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956575868CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956587267CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956590533CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956592476CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956598126CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956599550CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956601758CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956604209CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956606623CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10653160394327MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160394334MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160394488MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160394617MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160394969MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160394983MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160395027MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160395171MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160395188MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160395294MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10809160540657HalyardAVID MEDICAL, INC.LRO2026-10-15
10885632540639SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-10-15
10885632540646SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-10-15
10653160395287MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-14
10653160395324MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-14
10653160395416MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-14