FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956586789
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA33MLUWA
Catalog number
SBA33MLUWA
Device description
MAJOR LAPAROTOMY PACK
Published
2026-11-05
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
50198956586787PackageGS12In Commercial Distribution
10198956586789PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895658678750198956586787
1019895658678910198956586789

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
10192253005820Monoject8602U8602U2026-11-05
10192253005837Monoject8605U8605U2026-11-05
10192253005844Monoject8607U8607U2026-11-05
10192253005851Monoject8611U8611U2026-11-05
10192253005868Monoject8612U8612U2026-11-05
10192253043112Argyle888830160688883016062026-08-12
10192253043136Argyle888830161488883016142026-08-12
10192253043143Argyle888830162288883016222026-08-12
10192253043181Argyle888830171388883017132026-08-12
10192253043198Argyle888830172188883017212026-08-12
10198956196308CARDINAL HEALTHPO44KLCSDPO44KLCSD2026-11-05
10198956202214CARDINAL HEALTHSBA11BCNMNSBA11BCNMN2026-11-05
10198956270817CARDINAL HEALTHSOP38THBADSOP38THBAD2026-11-05
10198956341296CARDINAL HEALTHSOPDKATCH7SOPDKATCH72026-11-05
10198956346659CARDINAL HEALTHPNV2LMA01CPNV2LMA01C2026-11-05
10198956347021CARDINAL HEALTHSCV5DOVFANSCV5DOVFAN2026-11-05
10198956377486CARDINAL HEALTHSOP42AAJCGSOP42AAJCG2026-11-05
10198956390423CARDINAL HEALTHSOP34ARBCLSOP34ARBCL2026-11-05
10198956391123CARDINAL HEALTHSBAX3FFOHASBAX3FFOHA2026-11-05
10198956391666CARDINAL HEALTHSEY69BPZEBSEY69BPZEB2026-11-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956202214CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956391123CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956469266CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956475205CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956499294CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956503267CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956506503CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956509566CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956539792CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956554412CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956555808CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956567719CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956568020CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956568297CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956569935CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956573802CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956578173CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956581166CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956581180CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956584143CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956585355CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956586420CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956588325CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956588417CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956590762CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956590854CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956591059CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956591073CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956591158CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956592445CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05