FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10888439763546
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA69LB618
Catalog number
SBA69LB618
Device description
LAP CHOLE PACK
Published
2020-02-25
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
PKELaparoscopic Cholecystectomy Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKELaparoscopic Cholecystectomy KitGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50888439763544PackageGS11In Commercial Distribution
10888439763546PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843976354450888439763544
1088843976354610888439763546

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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
10198956382909CARDINAL HEALTHCardinal Health 200, LLCPKE2026-06-01
10304040166885Henry ScheinHENRY SCHEIN, INC.PKE2023-07-30
00304040166888Henry ScheinHENRY SCHEIN, INC.PKE2023-07-30
H65857031365Henry ScheinHENRY SCHEIN, INC.PKE2022-08-10
H65857031361Henry ScheinHENRY SCHEIN, INC.PKE2022-08-10
M75257029180Stradis Medical, LLC.STRADIS MEDICAL, LLCPKE2022-04-25
M7526902620STRADIS HEALTHCARESTRADIS MEDICAL, LLCPKE2022-03-21
M75257014820STRADIS HEALTHCARESTRADIS MEDICAL, LLCPKE2022-03-17
M7526902530STRADIS HEALTHCARESTRADIS MEDICAL, LLCPKE2022-03-17
10195594582845CARDINAL HEALTHCardinal Health 200, LLCPKE2022-03-11
50195594582843CARDINAL HEALTHCardinal Health 200, LLCPKE2022-03-11
M75257019510STRADIS HEALTHCARESTRADIS MEDICAL, LLCPKE2022-03-03
M752KPX3209A0STRADIS HEALTHCARESTRADIS MEDICAL, LLCPKE2022-03-03
00191072144430ACSAMERICAN CONTRACT SYSTEMS, INC.PKE2021-08-25
00191072120991ACSAMERICAN CONTRACT SYSTEMS, INC.PKE2021-01-05
00191072087409ACSAMERICAN CONTRACT SYSTEMS, INC.PKE2020-09-24
10888439831276CARDINAL HEALTHCardinal Health 200, LLCPKE2020-05-27
50888439831274CARDINAL HEALTHCardinal Health 200, LLCPKE2020-05-27
10888439782387CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-31
10888439795868CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-31
50888439782385CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-31
50888439795866CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-31
10888439793598CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-20
50888439793596CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-20
10888439678697CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-12
50888439678695CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-12
10888439766929CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-04
50888439766927CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-04
10888439771541CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-02
50888439771549CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-02