FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956550452
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA73GL07E
Catalog number
SBA73GL07E
Device description
GENERAL LAPAROSCOPY PACK
Published
2026-09-22
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
50198956550450PackageGS13In Commercial Distribution
10198956550452PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895655045050198956550450
1019895655045210198956550452

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
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956550483CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-25
10198956587359CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-25
10198956589254CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-25
10198956589315CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-25
10198956591240CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-25
10198956555716CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-22
10198956555938CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-22
10198956558342CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-22
10198956561892CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-22
10198956587434CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-22
10198956581500CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-21
10198956581586CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-21
10198956583696CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-21
10809160536858HalyardMEDICAL ACTION INDUSTRIES INC.FDE2026-09-18
10198956398467CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-04
10198956487468CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-04
10198956555778CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-04
10198956330221CARDINAL HEALTHCardinal Health 200, LLCFDE2026-08-26
10198956547742CARDINAL HEALTHCardinal Health 200, LLCFDE2026-08-26
10198956564473CARDINAL HEALTHCardinal Health 200, LLCFDE2026-08-26
10198956556805CARDINAL HEALTHCardinal Health 200, LLCFDE2026-08-18
10198956515871CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-31
10198956524354CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-31
10198956530805CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-31
10198956534421CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-31
10198956538573CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-31
10809160527931HALYARDAVID MEDICAL, INC.FDE2026-07-28
10198956218109CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
10198956360457CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
10198956378339CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27