FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50198956020052
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
OTC
false
Sterile
false
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.

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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50197106754793CARDINAL HEALTHCardinal Health 200, LLCPWU2024-09-24
00818634025524Bosma EnterprisesBosma EnterprisesPWU2024-03-15
10818634025538Bosma EnterprisesBosma EnterprisesPWU2024-03-15
10818634025583Bosma EnterprisesBosma EnterprisesPWU2024-03-15
10818634025590Bosma EnterprisesBosma EnterprisesPWU2024-03-15
00304040167977Henry ScheinHENRY SCHEIN, INC.PWU2023-07-30
50197106289912CARDINAL HEALTHCardinal Health 200, LLCPWU2023-06-15
M75257014920STRADIS HEALTHCARESTRADIS MEDICAL, LLCPWU2022-04-05
M75257027820STRADIS HEALTHCARESTRADIS MEDICAL, LLCPWU2022-03-10
50195594555731CARDINAL HEALTHCardinal Health 200, LLCPWU2022-03-03
50195594539175CARDINAL HEALTHCardinal Health 200, LLCPWU2022-02-18
50195594294821CARDINAL HEALTHCardinal Health 200, LLCPWU2022-01-11
00818634020222Bosma EnterprisesBosma EnterprisesPWU2021-07-02
10818634020236Bosma EnterprisesBosma EnterprisesPWU2021-07-02
10818634020243Bosma EnterprisesBosma EnterprisesPWU2021-07-02
10818634020250Bosma EnterprisesBosma EnterprisesPWU2021-07-02
10818634020267Bosma EnterprisesBosma EnterprisesPWU2021-07-02
10818634020274Bosma EnterprisesBosma EnterprisesPWU2021-07-02
10818634020281Bosma EnterprisesBosma EnterprisesPWU2021-07-02
10818634020298Bosma EnterprisesBosma EnterprisesPWU2021-07-02
10818634020304Bosma EnterprisesBosma EnterprisesPWU2021-07-02
10818634020311Bosma EnterprisesBosma EnterprisesPWU2021-07-02
10818634020328Bosma EnterprisesBosma EnterprisesPWU2021-07-02
10818634020335Bosma EnterprisesBosma EnterprisesPWU2021-07-02
10818634020342Bosma EnterprisesBosma EnterprisesPWU2021-07-02
00818634020352Bosma EnterprisesBosma EnterprisesPWU2021-07-02
10818634020366Bosma EnterprisesBosma EnterprisesPWU2021-07-02
10818634020373Bosma EnterprisesBosma EnterprisesPWU2021-07-02
10818634020380Bosma EnterprisesBosma EnterprisesPWU2021-07-02
10818634020397Bosma EnterprisesBosma EnterprisesPWU2021-07-02