FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10885425898169
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SLCW1LCWSE
Catalog number
SLCW1LCWSE
Device description
STERILE LAP CHOLE PACK
Published
2016-08-22
Public version status
Update
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
50885425898167PackageGS12In Commercial Distribution
10885425898169PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088542589816750885425898167
1088542589816910885425898169

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic surgical procedure kit, medicatedA collection of various sterile surgical and endoscopic instruments (e.g., trocars, sleeves, cannulae), dressings, pharmaceuticals, and the necessary materials used to perform a laparoscopic surgical procedure. 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
10192253004649Monoject8602RC8602RC2026-07-09
10192253004656Monoject8605RC8605RC2026-07-09
10192253004663Monoject8607RC8607RC2026-07-09
10192253004700Monoject8617RC8617RC2026-07-09
10192253051575Precision2650SA2650SA2026-07-09
10197106896327CARDINAL HEALTHSNENU0868BSNENU0868B2026-07-09
10198956074668CARDINAL HEALTHSBA37OTMOFSBA37OTMOF2026-07-09
10198956119260CARDINAL HEALTHSBA69MPSUBSBA69MPSUB2026-07-09
10198956119437CARDINAL HEALTHPVVMVPBLGPVVMVPBLG2026-07-09
10198956255586CARDINAL HEALTHSOP53SAPTHSOP53SAPTH2026-07-09
10198956268272CARDINAL HEALTHSMA54CSWMMSMA54CSWMM2026-07-09
10198956286719CARDINAL HEALTHSOT11BR10MSOT11BR10M2026-07-09
10198956307308CARDINAL HEALTHSAN43ADSWOSAN43ADSWO2026-07-09
10198956313576CARDINAL HEALTHSMA69BTDNBSMA69BTDNB2026-07-09
10198956333888CARDINAL HEALTHPBCGLSARGPBCGLSARG2026-07-09
10198956334373CARDINAL HEALTHSNECGBPNODSNECGBPNOD2026-07-09
10198956339132CARDINAL HEALTHSEYHDCAGWHSEYHDCAGWH2026-07-09
10198956345942CARDINAL HEALTHSANOCIRHTBSANOCIRHTB2026-07-09
10198956349834CARDINAL HEALTHSAN73PLCHMSAN73PLCHM2026-07-09
10198956360358CARDINAL HEALTHSCV73VPBHDSCV73VPBHD2026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956395039CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-09
10198956493599CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-09
10198956509337CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-09
10198956512672CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-09
10198956514416CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-09
10198956527041CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-09
10198956503618CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-06
B098AMS15230A0Aligned Medical SolutionsAligned Medical SolutionsFDE2026-06-25
10198956374119CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-08
10198956387171CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-08
10198956456778CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-08
10198956488137CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-08
10198956495968CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-08
10198956496279CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-08
10198956496620CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-08
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
10080196887248Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2025-01-19