FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106978825
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SER2DCCSGB
Catalog number
SER2DCCSGB
Device description
CLEAN CLOSURE PACK
Published
2025-10-03
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
PWUClean-up kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PWUClean-Up KitGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106978823PackageGS14In Commercial Distribution
10197106978825PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710697882350197106978823
1019710697882510197106978825

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, 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.

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
50885380213234Kendall3320533205B2026-10-28
50885380213241Kendall3320633206B2026-10-28
50885380213258Kendall3320733207B2026-10-28
10885380169922CARDINAL HEALTH212WPR212WPR2020-01-13
20884521100449Monoject8611U8611U2016-09-24
20884521100456Monoject8612U8612U2016-09-24
20192253024668Monoject888120201888812020182026-07-15
10192253040203Argyle1604091604092025-01-08
10192253040210Argyle43201432012025-01-08
10192253040241Argyle43308433082025-01-08
10192253040258Argyle43309433092025-01-08
10192253040265Argyle43311433112025-01-08
10192253040289Argyle888816011988881601192025-01-08
10192253040326Argyle888816040888881604082025-01-08
10192253040333Argyle888816042488881604242025-01-08
10192253040340Argyle888816043288881604322025-01-08
10192253040395Argyle888816083888881608382025-01-08
10192253040401Argyle888816085388881608532025-01-08
10192253046656Kendall55566BAMD55566BAMD2023-10-09
10195594567743CARDINAL HEALTHSBACNUBOL3SBACNUBOL32022-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818634020635Bosma EnterprisesBosma EnterprisesPWU2026-05-14
00818634025210Bosma EnterprisesBosma EnterprisesPWU2026-05-14
00818634025838Bosma EnterprisesBosma EnterprisesPWU2026-05-14
00818634026040Bosma EnterprisesBosma EnterprisesPWU2026-05-14
00818634025807Bosma EnterprisesBosma EnterprisesPWU2026-04-14
00818634025821Bosma EnterprisesBosma EnterprisesPWU2026-04-14
00818634025890Bosma EnterprisesBosma EnterprisesPWU2026-04-14
00818634026019Bosma EnterprisesBosma EnterprisesPWU2026-04-14
00818634026026Bosma EnterprisesBosma EnterprisesPWU2026-04-14
00818634026033Bosma EnterprisesBosma EnterprisesPWU2026-04-14
10198956020054CARDINAL HEALTHCardinal Health 200, LLCPWU2025-03-14
50198956020052CARDINAL HEALTHCardinal Health 200, LLCPWU2025-03-14
10197106754795CARDINAL HEALTHCardinal Health 200, LLCPWU2024-09-24
50197106754793CARDINAL HEALTHCardinal Health 200, LLCPWU2024-09-24
00818634025531Bosma EnterprisesBosma EnterprisesPWU2024-03-15
00818634025586Bosma EnterprisesBosma EnterprisesPWU2024-03-15
00818634025593Bosma EnterprisesBosma EnterprisesPWU2024-03-15
00818634025524Bosma EnterprisesBosma EnterprisesPWU2024-03-15
10818634025538Bosma EnterprisesBosma EnterprisesPWU2024-03-15
10818634025583Bosma EnterprisesBosma EnterprisesPWU2024-03-15
10818634025590Bosma EnterprisesBosma EnterprisesPWU2024-03-15
10304040167974Henry ScheinHENRY SCHEIN, INC.PWU2023-07-30
00304040167977Henry ScheinHENRY SCHEIN, INC.PWU2023-07-30
10197106289914CARDINAL HEALTHCardinal Health 200, LLCPWU2023-06-15
50197106289912CARDINAL HEALTHCardinal Health 200, LLCPWU2023-06-15
M75257014920STRADIS HEALTHCARESTRADIS MEDICAL, LLCPWU2022-04-05
M75257027820STRADIS HEALTHCARESTRADIS MEDICAL, LLCPWU2022-03-10
10195594555733CARDINAL HEALTHCardinal Health 200, LLCPWU2022-03-03
50195594555731CARDINAL HEALTHCardinal Health 200, LLCPWU2022-03-03
10195594539177CARDINAL HEALTHCardinal Health 200, LLCPWU2022-02-18