FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10888439396409
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SLC29LPRM2
Catalog number
SLC29LPRM2
Device description
LAP CHOLE
Published
2019-02-27
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
50888439396407PackageGS12In Commercial Distribution
10888439396409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843939640750888439396407
1088843939640910888439396409

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 Temperature15 Degrees Celsius30 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
10198956078789CARDINAL HEALTHSBACGTPILESBACGTPILE2026-06-05
10198956231061CARDINAL HEALTHSMA45CSHMCSMA45CSHMC2026-06-05
10198956266063CARDINAL HEALTHSEN32MHRMJSEN32MHRMJ2026-06-05
10198956286665CARDINAL HEALTHPOV2SH01YPOV2SH01Y2026-06-05
10198956305274CARDINAL HEALTHSOP21BPWCBSOP21BPWCB2026-06-05
10198956305861CARDINAL HEALTHSBA30HYCRGSBA30HYCRG2026-06-05
10198956321557CARDINAL HEALTHPVHDMJVCOPVHDMJVCO2026-06-05
10198956330085CARDINAL HEALTHPV13OPEMIPV13OPEMI2026-06-05
10198956332522CARDINAL HEALTHSNE24CRNOOSNE24CRNOO2026-06-05
10198956339231CARDINAL HEALTHSCV22EPSBDSCV22EPSBD2026-06-05
10198956339392CARDINAL HEALTHSBA21BLDCCSBA21BLDCC2026-06-05
10198956344471CARDINAL HEALTHPB4AGYHAFPB4AGYHAF2026-06-05
10198956345928CARDINAL HEALTHSOPOCCAHSCSOPOCCAHSC2026-06-05
10198956349261CARDINAL HEALTHSBA40TRCFESBA40TRCFE2026-06-05
10198956353268CARDINAL HEALTHSCV29SPMMCSCV29SPMMC2026-06-05
10198956354241CARDINAL HEALTHSEN4LHNGRESEN4LHNGRE2026-06-05
10198956359963CARDINAL HEALTHSOP56THIDFSOP56THIDF2026-06-05
10198956364905CARDINAL HEALTHSOP5TKASCFSOP5TKASCF2026-06-05
10198956365902CARDINAL HEALTHSBA22BSSTDSBA22BSSTD2026-06-05
10198956367630CARDINAL HEALTHSOT69CYUSESOT69CYUSE2026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956339392CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-05
10198956376748CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-05
10198956475502CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-05
10198956483743CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-05
10198956467675CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-03
10198956469280CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-03
10198956488656CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-03
10198956494459CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-03
10198956495500CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-03
10198956380455CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-01
10198956431935CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-01
10198956439580CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-01
10198956487208CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-01
10198956487826CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-01
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