FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956020054
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
ORC241074C
Catalog number
ORC241074C
Device description
KIT, CLEAN UP
Published
2025-03-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
50198956020052PackageGS113In Commercial Distribution
10198956020054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895602005250198956020052
1019895602005410198956020054

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
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

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
10197106978825CARDINAL HEALTHCardinal Health 200, LLCPWU2025-10-03
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