FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594198587
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
OTC
false
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

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
10198956106666CARDINAL HEALTHSAN23PMPRHSAN23PMPRH2026-10-23
10198956201606CARDINAL HEALTHPOV2ASNULPOV2ASNUL2026-10-23
10198956318748CARDINAL HEALTHSAN42RPIRBSAN42RPIRB2026-10-23
10198956332553CARDINAL HEALTHPNVNNECHVPNVNNECHV2026-10-23
10198956409552CARDINAL HEALTHSCV40CVKUGSCV40CVKUG2026-10-23
10198956433113CARDINAL HEALTHSEN40EPWEDSEN40EPWED2026-10-23
10198956460942CARDINAL HEALTHSBA69BPSABSBA69BPSAB2026-10-23
10198956463417CARDINAL HEALTHPB41GLLAEPB41GLLAE2026-10-23
10198956487918CARDINAL HEALTHSOPHDTPMSCSOPHDTPMSC2026-10-23
10198956504899CARDINAL HEALTHSNE12CRKGOSNE12CRKGO2026-10-23
10198956505766CARDINAL HEALTHSOPCNARCRESOPCNARCRE2026-10-23
10198956506572CARDINAL HEALTHSOT7ECPSSESOT7ECPSSE2026-10-23
10198956508682CARDINAL HEALTHSOP53TPNABSOP53TPNAB2026-10-23
10198956530157CARDINAL HEALTHSAN11IRLVLSAN11IRLVL2026-10-23
10198956530799CARDINAL HEALTH34-0748B34-0748B2026-10-23
10198956534834CARDINAL HEALTHSANOCCCPOFSANOCCCPOF2026-10-23
10198956544123CARDINAL HEALTHPG08GMPCBPG08GMPCB2026-10-23
10198956548923CARDINAL HEALTHSNE33SPMACSNE33SPMAC2026-10-23
10198956549524CARDINAL HEALTHSBA11LYMMJSBA11LYMMJ2026-10-23
10198956553552CARDINAL HEALTHSOP41TPSGGSOP41TPSGG2026-10-23

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