FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956610231
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
END4883419
Catalog number
END4883419
Device description
KIT, ENDO
Published
2026-10-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
50198956610239PackageGS112In Commercial Distribution
10198956610231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895661023950198956610239
1019895661023110198956610231

GMDN Terms#

Term, Definition table
TermDefinition
Urological surgical procedure kit, non-medicated, single-useA collection of various urological surgical instruments and the necessary materials intended to be used during a urological surgical/endoscopic procedure; it is not a dedicated bladder irrigation set. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of urological surgical procedure, but are often supplied together to perform a specific type of urological procedure; it does not contain any pharmaceuticals. 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
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
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
10198956593862CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-29