FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956616585
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA69RPKH9
Catalog number
SBA69RPKH9
Device description
SAN LEANDRO ROBOTIC PACK
Published
2026-10-26
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
NWUEndoscope introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWUEndoscope Introducer KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956616583PackageGS11In Commercial Distribution
10198956616585PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895661658350198956616583
1019895661658510198956616585

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic surgical procedure kit, non-medicated, single-useA collection of various sterile laparoscopic and surgical instruments (e.g., access cannulae, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. 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
10198956615533CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-26
10198956616639CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-26
10198956616752CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-26
10198956506572CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-23
10198956595194CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-23
10198956598553CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-23
10198956613157CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-23
10198956615397CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-23
06936603237397GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
06936603237403GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
06936603237410GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
06936603237427GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
06936603237434GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
06936603237441GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
06936603237458GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
06936603237465GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
06936603237489GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
06936603237496GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
06936603237502GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
10198956553903CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956569331CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956595965CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956598355CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956602236CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956605442CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956605497CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956605640CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956607743CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956609723CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956609976CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19