FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50888439645215
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA22GLWRB
Catalog number
SBA22GLWRB
Device description
GENERAL LAPAROSCOPIC PACK
Published
2020-01-11
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
50888439645215PackageGS12In Commercial Distribution
10888439645217PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843964521550888439645215
1088843964521710888439645217

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.

Sterilization Methods#

Method table
Method

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
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10080196926213Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2025-01-19
10193489213928Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2024-07-29
10080196498192Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-07-29
10080196498345Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-07-29
10193489211658Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-06-08
10193489212594Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-06-08
10193489213003Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-06-08
10193489213515Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-06-08