FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106969159
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA21GLA13
Catalog number
SBA21GLA13
Device description
ATHENS GENERAL LAPAROSCOPY PK
Published
2025-02-28
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
50197106969159PackageGS12In Commercial Distribution
10197106969151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710696915950197106969159
1019710696915110197106969151

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
10192253033502Monoject118030055511803005552022-10-21
10630140029332CONVERTORS29459294592016-06-28
10630140031403CONVERTORS29461294612016-06-28
10885380026577CONVERTORS29435294352016-06-28
10885380034862CONVERTORS74210742102016-06-28
10885380038075CONVERTORS29520295202016-06-28
10885380053740CONVERTORS29456294562016-06-22
10885380058134CONVERTORSD1062D10622016-06-29
10885380058387CONVERTORS945094502016-06-28
10885380062278CONVERTORS944494442016-06-22
10885380062285CONVERTORS755475542016-06-28
10885380062308CONVERTORS955695562016-07-08
10885380063664CONVERTORS29452294522016-06-28
10885380071539CONVERTORS956295622016-07-13
10885380071652CONVERTORS29417294172016-06-28
10885380071690CONVERTORS29458294582016-06-28
10885380108624CONVERTORS29430294302016-06-22
10885380108648CONVERTORS29447294472016-06-22
10885380108655CONVERTORS29448294482016-06-22
10885380108662CONVERTORS29449294492016-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10193489214116Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-06-08
10193489214154Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-06-08
10193489215472Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-06-08
10193489216769Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-06-08
10193489287592Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489288285Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489288407Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489288414Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489289732Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489289749Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489289848Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09