FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594198589
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA23LPHM2
Catalog number
SBA23LPHM2
Device description
LAPAROSCOPY PACK II
Published
2021-08-02
Public version status
New
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
FDElaparoscopy kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDELaparoscopy KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594198587PackageGS12In Commercial Distribution
10195594198589PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559419858750195594198587
1019559419858910195594198589

GMDN Terms#

Term, Definition table
TermDefinition
Decontamination floor mat, single-useA pad made of coarse, durable material that is designed to be placed on the floor to wipe the soles of the footwear of persons walking on its surface. The product is intended to reduce the distribution of dirt/contaminated materials on the floor. The product is for single-use and is not washed or cleaned for reuse. It may be a pad of layered adhesive sheets that bind dirt touching the surface; when the sheet is sufficiently saturated it is peeled off and discarded to reveal a new adhesive surface.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature040 Degrees Celsius

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
00885380173700Curity1806G1806G2026-10-26
10192253010015Kangaroo7761507761502026-10-26
10198956294127CARDINAL HEALTHSOPHDTHWWCSOPHDTHWWC2026-10-26
10198956515376CARDINAL HEALTHSBA69FFKWRSBA69FFKWR2026-10-26
10198956516342CARDINAL HEALTHSMA54GLPOISMA54GLPOI2026-10-26
10198956519138CARDINAL HEALTHSMA55CPYKFSMA55CPYKF2026-10-26
10198956542006CARDINAL HEALTH20-485AI20-485AI2026-10-26
10198956555839CARDINAL HEALTHAMN696315EAMN696315E2026-10-26
10198956562905CARDINAL HEALTHSEY57KC00GSEY57KC00G2026-10-26
10198956565784CARDINAL HEALTHSNEOCSPSBCSNEOCSPSBC2026-10-26
10198956566705CARDINAL HEALTHPN41LMLAKPN41LMLAK2026-10-26
10198956568884CARDINAL HEALTH27-9143M27-9143M2026-10-26
10198956573437CARDINAL HEALTHSAN12AIUVFSAN12AIUVF2026-10-26
10198956575028CARDINAL HEALTHSMA73UGKSISMA73UGKSI2026-10-26
10198956576940CARDINAL HEALTHSOP69SH45CSOP69SH45C2026-10-26
10198956577107CARDINAL HEALTHSEN4AEAJHWSEN4AEAJHW2026-10-26
10198956577282CARDINAL HEALTHSBAOCMBKCRSBAOCMBKCR2026-10-26
10198956578869CARDINAL HEALTHSBAOCMJWYJSBAOCMJWYJ2026-10-26
10198956590359CARDINAL HEALTHSBA4QFLFPCSBA4QFLFPC2026-10-26
10198956591981CARDINAL HEALTHSOP69EEKRESOP69EEKRE2026-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956549524CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-23
10198956575172CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956589940CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956590847CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956599055CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956602700CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956602717CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956603547CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956605633CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956606265CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956608238CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956609624CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956609686CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956602861CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-15
B098AMS198710Aligned Medical SolutionsAligned Medical SolutionsFDE2026-10-14
10198956586574CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-12
10198956596764CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-12
10198956597570CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-12
10198956506121CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-06
10198956599222CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-06
10198956604896CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-06
10198956610231CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-06
B098AMS16041C0Aligned Medical SolutionsAligned Medical SolutionsFDE2026-10-02
10198956594845CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-30
10198956596528CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-30
10198956567597CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-29
10198956568037CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-29
10198956590243CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-29
10198956591479CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-29
10198956592773CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-29